Recurrent Large Cell Lung Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Squamous Cell Lung Carcinoma, Stage IV Large Cell Lung Carcinoma, Stage IV Lung Adenocarcinoma, Stage IV Squamous Cell Lung Carcinoma
Conditions
Brief summary
This randomized phase III trial studies carboplatin and paclitaxel to compare how well they work with or without bevacizumab and/or cetuximab in treating patients with stage IV or non-small cell lung cancer that has returned after a period of improvement (recurrent). Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumor needs to grow. Cetuximab may also stop cancer cells from growing by binding and interfering with a protein on the surface of the tumor cell that is needed for tumor growth. It is not yet known whether giving carboplatin and paclitaxel are more effective with or without bevacizumab and/or cetuximab in treating patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES: I. To compare overall survival (OS) in the entire study population. II. To compare progression-free survival (PFS) by institutional review of epidermal growth factor receptor (EGFR) fluorescent in situ hybridization (FISH)-positive patients. SECONDARY OBJECTIVES: I. To compare OS and PFS by centralized review in EGFR FISH-positive patients. II. To compare PFS by centralized image review and by institutional review in the entire study population. III. To compare the response rate (confirmed plus unconfirmed, complete and partial responses) in a subset of patients with measurable disease in EGFR FISH-positive patient and the entire study population. IV. To assess the toxicities of these treatment regimens. V. To prospectively test EGFR FISH as a predictive marker for the selection of patients for cetuximab plus chemotherapy. III. To evaluate the role of V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations in terms of cetuximab efficacy. IV. To compare the results of EGFR FISH with KRAS mutations, EGFR mutations, EGFR immunohistochemistry (IHC), and other purported EGFR-related biomarkers. TERTIARY OBJECTIVES: I. To compare PFS in patients with advanced non-small cell lung cancer (NSCLC) with an IHC score \> 200 treated with carboplatin, paclitaxel, and bevacizumab (if appropriate) with or without cetuximab. II. To compare OS in patients with advanced NSCLC with an IHC score \> 200 treated with carboplatin, paclitaxel, and bevacizumab (if appropriate) with or without cetuximab. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.
Interventions
Given IV
Given IV
Given IV
Correlative studies
Given IV
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients must have histologically or cytologically proven primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified); disease must be stage IV; disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease will not be considered to have stage IV disease and are not eligible * Patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day * Patients may have measurable or non-measurable disease documented by CT or MRI; the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form * Patients must have tumor tissue available for submission that is sufficient for EGFR FISH testing and must agree to submission of these specimens; patients must also agree to submission of specimens for other translational medicine studies; patient must be offered participation in banking for future research * Patients must not have received prior chemotherapy for any stage non-small cell lung cancer; patients must not have received prior platinum-based chemotherapy for any purpose; patient must not have received any cetuximab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway; patients must not have received for any purpose prior bevacizumab or other vascular endothelial growth factor (VEGF)-related agents; patients must not have received for any purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA) * Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration; in order to qualify as measurable, measurable disease must be outside the previous radiation field or must have progressed * Time from surgical or biopsy procedures is dependent on whether it is planned for the patient to receive bevacizumab * For patients who are bevacizumab-appropriate AND bevacizumab is planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or video-assisted thoracoscopic surgery \[VATS\] resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 14 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), thoracentesis or central venous access device implanted within 7 days prior to registration; for other surgical procedures not listed here, please contact the study coordinators * For patients who are bevacizumab-inappropriate or bevacizumab is not planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or VATS resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 7 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), or thoracentesis within 1 day prior to registration; patients may have had a central venous access device placed at any time prior to registration; for other surgical procedures not listed here, please contact the study coordinators * Absolute neutrophil count (ANC) \>= 1,500/mcl * Platelet count \>= 100,000/mcl * Hemoglobin \>= 9 g/dL * Serum creatinine =\< institutional upper limit of normal (IULN) AND calculated or measured creatinine clearance \>= 50 cc/min using the following Cockroft-Gault formula * For patients who will be receiving bevacizumab, urine protein must be screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein must be obtained and the level must be \< 1,000 mg for patient enrollment; the urine protein used to calculate the UPC ratio must be obtained within 14 days prior to registration; UPC or 24-hour protein is not required for patients who will not receive bevacizumab Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm * Serum bilirubin =\< 2 times IULN (for patients with liver metastases, bilirubin must be =\< 5 X IULN) * Serum glutamic oxaloacetic transaminase (SGOT) OR serum glutamate pyruvate transaminase (SGPT) =\< 2 times IULN (for patients with liver metastases, either SGOT or SGPT must be =\< 5 X IULN) * Zubrod performance status 0-1 * Patients must not have \>= grade 2 symptomatic neuropathy-sensory (National Cancer Institute \[NCI\] Common Terminology Criteria version 3.0) * Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection * Patients must not have the following: history (within past 6 months) of cerebrovascular accident (CVA), myocardial infarction or unstable angina; or at the time of registration, uncontrolled hypertension, New York Heart Association grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or clinically significant peripheral vascular disease * Patients must have no known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (examples include trastuzumab \[Herceptin\] and epoetin alpha) * Patients must be willing to provide prior smoking history * No other prior malignancy is allowed except for any of the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer from which the patient is currently in complete remission * Any other cancer from which the patient has been disease-free for 5 years * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) in the Entire Study Population | Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years | From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Progression-Free Survival (PFS) of the Entire Study Population by Centralized Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Overall Survival (OS) of EGFR FISH-positive Patients | Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years | From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Toxicity assessment was evaluated every 3 weeks while one protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression or unacceptable toxicity. | Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. |
| Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients | Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression. | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Progression-Free Survival (PFS) of EGFR FISH-positive Patients by Centralized Review | Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression. | From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Countries
Mexico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Chemo +/- Bevacizumab) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV | 657 |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Cetuximab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV | 656 |
| Total | 1,313 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 118 | 124 |
| Overall Study | Death | 21 | 22 |
| Overall Study | Disease progression | 308 | 404 |
| Overall Study | Ineligible | 14 | 6 |
| Overall Study | No treatment given | 25 | 29 |
| Overall Study | On Treatment | 0 | 4 |
| Overall Study | Other reasons | 61 | 73 |
Baseline characteristics
| Characteristic | Arm I (Chemo +/- Bevacizumab) | Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Total |
|---|---|---|---|
| Age, Continuous | 63 years | 63 years | 63 years |
| Age, Customized Age, Categorized Age <= 65 | 379 Participants | 381 Participants | 760 Participants |
| Age, Customized Age, Categorized Age > 65 | 278 Participants | 275 Participants | 553 Participants |
| Bevacizumab treatment No | 380 Participants | 373 Participants | 753 Participants |
| Bevacizumab treatment Yes | 277 Participants | 283 Participants | 560 Participants |
| EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status Negative | 293 Participants | 283 Participants | 576 Participants |
| EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status Positive | 201 Participants | 199 Participants | 400 Participants |
| EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status Unknown | 163 Participants | 174 Participants | 337 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 16 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 606 Participants | 618 Participants | 1224 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 22 Participants | 47 Participants |
| Histology Adenocarcinoma | 408 Participants | 411 Participants | 819 Participants |
| Histology Other | 88 Participants | 85 Participants | 173 Participants |
| Histology Squamous cell carcinoma | 161 Participants | 160 Participants | 321 Participants |
| M-stage M1a | 148 Participants | 150 Participants | 298 Participants |
| M-stage M1b | 509 Participants | 506 Participants | 1015 Participants |
| Performance Status 0 | 229 Participants | 256 Participants | 485 Participants |
| Performance Status 1 | 427 Participants | 400 Participants | 827 Participants |
| Performance Status Missing Data | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 10 Participants | 18 Participants | 28 Participants |
| Race/Ethnicity, Customized Race Black | 61 Participants | 55 Participants | 116 Participants |
| Race/Ethnicity, Customized Race Native American | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Pacific Islander | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Unknown | 16 Participants | 8 Participants | 24 Participants |
| Race/Ethnicity, Customized Race White | 565 Participants | 568 Participants | 1133 Participants |
| Sex: Female, Male Female | 298 Participants | 271 Participants | 569 Participants |
| Sex: Female, Male Male | 359 Participants | 385 Participants | 744 Participants |
| Smoking History Current | 297 Participants | 292 Participants | 589 Participants |
| Smoking History Former | 303 Participants | 305 Participants | 608 Participants |
| Smoking History Never | 57 Participants | 59 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 593 / 657 | 570 / 656 |
| other Total, other adverse events | 619 / 632 | 611 / 627 |
| serious Total, serious adverse events | 66 / 632 | 97 / 627 |
Outcome results
Overall Survival (OS) in the Entire Study Population
From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years
Population: All eligible patients are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Chemo +/- Bevacizumab) | Overall Survival (OS) in the Entire Study Population | 9.2 months |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Overall Survival (OS) in the Entire Study Population | 10.9 months |
Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.
Population: Eligible patients with EGFR FISH positive are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Chemo +/- Bevacizumab) | Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review | 4.8 months |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review | 5.4 months |
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Toxicity assessment was evaluated every 3 weeks while one protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression or unacceptable toxicity.
Population: Limited to eligible patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 26 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuroendocrine: ADH secretion abnormality | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuropathy: motor | 18 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuropathy: sensory | 57 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophils/granulocytes (ANC/AGC) | 158 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Obstruction, GI - Small bowel NOS | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Obstruction/stenosis of airway - Bronchus | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ocular/Visual-Other (Specify) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Opportunistic inf associated w/gt=Gr 2 lymphopenia | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Abdomen NOS | 5 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Back | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Bone | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Chest wall | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Chest/thorax NOS | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Extremity-limb | 10 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Head/headache | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Joint | 19 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Muscle | 24 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Neck | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Neuralgia/peripheral nerve | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Oral cavity | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Peritoneum | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Scrotum | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Skin | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Stomach | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain-Other (Specify) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pancreatitis | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Perforation, GI - Colon | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Perforation, GI - Duodenum | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Perforation, GI - Small bowel NOS | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pericardial effusion (non-malignant) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Phosphate, serum-low (hypophosphatemia) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Platelets | 51 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pleural effusion (non-malignant) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pneumonitis/pulmonary infiltrates | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Potassium, serum-high (hyperkalemia) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Potassium, serum-low (hypokalemia) | 22 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Proteinuria | 4 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pruritus/itching | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pulmonary/Upper Respiratory-Other (Specify) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash/desquamation | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash: acne/acneiform | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash: hand-foot skin reaction | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Renal failure | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Renal/Genitourinary-Other (Specify) | 3 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Atrial fibrillation | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Atrial flutter | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - SVT tachycardia | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Sinus tachycardia | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Seizure | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sodium, serum-low (hyponatremia) | 29 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Somnolence/depressed level of consciousness | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sudden death | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syncope (fainting) | 8 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syndromes-Other (Specify) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thrombosis/embolism (vascular access-related) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thrombosis/thrombus/embolism | 26 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tinnitus | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tremor | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tumor lysis syndrome | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Typhlitis (cecal inflammation) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ulcer, GI - Duodenum | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ulcer, GI - Stomach | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ulceration | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Uric acid, serum-high (hyperuricemia) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urticaria (hives, welts, wheals) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ventricular arrhythmia - Ventricular tachycardia | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ventricular arrhythmia NOS | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Visceral arterial ischemia (non-myocardial) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 19 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Weight gain | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Weight loss | 8 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Wound complication, non-infectious | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Lung (pneumonia) | 5 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (clinical exam) - Oral cavity | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | ALT, SGPT (serum glutamic pyruvic transaminase) | 5 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AST, SGOT | 6 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Acidosis (metabolic or respiratory) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Adrenal insufficiency | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Albumin, serum-low (hypoalbuminemia) | 8 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alkaline phosphatase | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Allergic reaction/hypersensitivity | 9 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Allergy/Immunology-Other (Specify) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Anorexia | 22 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Apnea | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Aspiration | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ataxia (incoordination) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bilirubin (hyperbilirubinemia) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Blood/Bone Marrow-Other (Specify) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bronchospasm, wheezing | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | CNS cerebrovascular ischemia | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Calcium, serum-high (hypercalcemia) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Calcium, serum-low (hypocalcemia) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Carbon monoxide diffusion capacity (DL(co)) | 3 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac General-Other (Specify) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac troponin I (cTnI) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac-ischemia/infarction | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiopulmonary arrest, cause unknown (non-fatal) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cognitive disturbance | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Colitis | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Colitis, infectious (e.g., Clostridium difficile) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Conduction abnormality - Asystole | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Confusion | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Constipation | 4 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cough | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Creatinine | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cytokine release syndrome/acute infusion reaction | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Death - Multi-organ failure | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Death not associated with CTCAE term - Death NOS | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dehydration | 27 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dermatology/Skin-Other (Specify) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Diarrhea | 15 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dizziness | 10 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry eye syndrome | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry mouth/salivary gland (xerostomia) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry skin | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dysphagia (difficulty swallowing) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dyspnea (shortness of breath) | 21 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Edema: limb | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Encephalopathy | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Esophagitis | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Extrapyramidal/involuntary movement/restlessness | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Eyelid dysfunction | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue (asthenia, lethargy, malaise) | 74 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 27 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | GGT (gamma-glutamyl transpeptidase) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gastritis (including bile reflux gastritis) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gastrointestinal-Other (Specify) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Glucose, serum-high (hyperglycemia) | 20 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Glucose, serum-low (hypoglycemia) | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Heartburn/dyspepsia | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemoglobin | 60 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemolysis | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Abdomen NOS | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Duodenum | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Esophagus | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Jejunum | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Lower GI NOS | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Upper GI NOS | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Varices (esophageal) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Varices (rectal) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Lung | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Nose | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Pleura | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage/Bleeding-Other (Specify) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hiccoughs (hiccups, singultus) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hot flashes/flushes | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 28 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypotension | 5 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypoxia | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | INR (of prothrombin time) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 8 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Duodenum | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 9 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Pleura | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Bladder | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Dental | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Joint | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 11 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Mucosa | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Pelvis | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Pleura | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Blood | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Eye NOS | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Sinus | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Skin (cellulitis) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Upper airway NOS | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Urinary tract NOS | 2 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Wound | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection-Other (Specify) | 4 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Insomnia | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Irregular menses (change from baseline) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Leukocytes (total WBC) | 74 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Leukoencephalopathy (radiolographic findings) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Local complication - device/prosthesis-related | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lymphopenia | 39 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Magnesium, serum-high (hypermagnesemia) | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Magnesium, serum-low (hypomagnesemia) | 6 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Memory impairment | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mental status | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Metabolic/Laboratory-Other (Specify) | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mood alteration - anxiety | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mood alteration - depression | 3 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (clinical exam) - Esophagus | 1 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-lower | 6 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-upper | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Pelvic | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - body/general | 21 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nail changes | 0 Participants |
| Arm I (Chemo +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nasal cavity/paranasal sinus reactions | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Confusion | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nausea | 30 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Skin (cellulitis) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuroendocrine: ADH secretion abnormality | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Constipation | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuropathy: motor | 10 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neuropathy: sensory | 36 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cough | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Neutrophils/granulocytes (ANC/AGC) | 210 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Memory impairment | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Obstruction, GI - Small bowel NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Creatinine | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Obstruction/stenosis of airway - Bronchus | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ocular/Visual-Other (Specify) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cytokine release syndrome/acute infusion reaction | 10 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Opportunistic inf associated w/gt=Gr 2 lymphopenia | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Upper airway NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Abdomen NOS | 9 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Chest wall | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Death - Multi-organ failure | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Back | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Colon | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Bone | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Death not associated with CTCAE term - Death NOS | 7 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nail changes | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Chest/thorax NOS | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dehydration | 31 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Extremity-limb | 12 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Duodenum | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Head/headache | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dermatology/Skin-Other (Specify) | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Joint | 19 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Urinary tract NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Muscle | 14 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Diarrhea | 19 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Neck | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Neuralgia/peripheral nerve | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dizziness | 7 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Oral cavity | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mental status | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Peritoneum | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry eye syndrome | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Scrotum | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 7 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Skin | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry mouth/salivary gland (xerostomia) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain - Stomach | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Wound | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pain-Other (Specify) | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dry skin | 6 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pancreatitis | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Perforation, GI - Colon | 6 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dysphagia (difficulty swallowing) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Perforation, GI - Duodenum | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-lower | 9 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Perforation, GI - Small bowel NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Dyspnea (shortness of breath) | 33 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pericardial effusion (non-malignant) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Pleura | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Phosphate, serum-low (hypophosphatemia) | 8 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Edema: limb | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Platelets | 43 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection-Other (Specify) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pleural effusion (non-malignant) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Encephalopathy | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pneumonitis/pulmonary infiltrates | 8 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Skin | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Potassium, serum-high (hyperkalemia) | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Esophagitis | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Potassium, serum-low (hypokalemia) | 35 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Metabolic/Laboratory-Other (Specify) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Proteinuria | 7 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Extrapyramidal/involuntary movement/restlessness | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pruritus/itching | 7 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - UTI | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Pulmonary/Upper Respiratory-Other (Specify) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Eyelid dysfunction | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash/desquamation | 6 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Insomnia | 5 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash: acne/acneiform | 50 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fatigue (asthenia, lethargy, malaise) | 81 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Rash: hand-foot skin reaction | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Bladder | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Renal failure | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Febrile neutropenia | 29 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Renal/Genitourinary-Other (Specify) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - body/general | 33 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Atrial fibrillation | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Atrial flutter | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Blood | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - SVT tachycardia | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | GGT (gamma-glutamyl transpeptidase) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | SVT and nodal arrhythmia - Sinus tachycardia | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Irregular menses (change from baseline) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Seizure | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gastritis (including bile reflux gastritis) | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sodium, serum-low (hyponatremia) | 27 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Catheter | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Somnolence/depressed level of consciousness | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Gastrointestinal-Other (Specify) | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Sudden death | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mood alteration - anxiety | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syncope (fainting) | 7 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Glucose, serum-high (hyperglycemia) | 13 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Syndromes-Other (Specify) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Dental | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thrombosis/embolism (vascular access-related) | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Glucose, serum-low (hypoglycemia) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Thrombosis/thrombus/embolism | 37 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Leukocytes (total WBC) | 103 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tinnitus | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Heartburn/dyspepsia | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tremor | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Joint | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Tumor lysis syndrome | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemoglobin | 48 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Typhlitis (cecal inflammation) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Extrem-upper | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ulcer, GI - Duodenum | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemolysis | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ulcer, GI - Stomach | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 8 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ulceration | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Abdomen NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Uric acid, serum-high (hyperuricemia) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Leukoencephalopathy (radiolographic findings) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Urticaria (hives, welts, wheals) | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Duodenum | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ventricular arrhythmia - Ventricular tachycardia | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Mucosa | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ventricular arrhythmia NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Esophagus | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Visceral arterial ischemia (non-myocardial) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mood alteration - depression | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Vomiting | 18 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Jejunum | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Weight gain | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Pelvis | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Weight loss | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Lower GI NOS | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Wound complication, non-infectious | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Local complication - device/prosthesis-related | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Lung (pneumonia) | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (clinical exam) - Esophagus | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Upper GI NOS | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | ALT, SGPT (serum glutamic pyruvic transaminase) | 8 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Varices (esophageal) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | AST, SGOT | 8 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Nasal cavity/paranasal sinus reactions | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Acidosis (metabolic or respiratory) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, GI - Varices (rectal) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Adrenal insufficiency | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Pleura | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Albumin, serum-low (hypoalbuminemia) | 7 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Alkaline phosphatase | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Lymphopenia | 60 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Allergic reaction/hypersensitivity | 41 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Lung | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Allergy/Immunology-Other (Specify) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - Skin | 5 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Anorexia | 25 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Nose | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Apnea | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (clinical exam) - Oral cavity | 6 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Aspiration | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage, pulmonary/upper respiratory - Pleura | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Ataxia (incoordination) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bilirubin (hyperbilirubinemia) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hemorrhage/Bleeding-Other (Specify) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Blood/Bone Marrow-Other (Specify) | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Magnesium, serum-high (hypermagnesemia) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Bronchospasm, wheezing | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hiccoughs (hiccups, singultus) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | CNS cerebrovascular ischemia | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Blood | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Calcium, serum-high (hypercalcemia) | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hot flashes/flushes | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Calcium, serum-low (hypocalcemia) | 8 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Muscle weakness, not d/t neuropathy - Pelvic | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Carbon monoxide diffusion capacity (DL(co)) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypertension | 17 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac General-Other (Specify) | 3 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Eye NOS | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac troponin I (cTnI) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypotension | 11 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiac-ischemia/infarction | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Magnesium, serum-low (hypomagnesemia) | 28 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cardiopulmonary arrest, cause unknown (non-fatal) | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Hypoxia | 6 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Cognitive disturbance | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Infection with unknown ANC - Sinus | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Colitis | 2 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | INR (of prothrombin time) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Colitis, infectious (e.g., Clostridium difficile) | 1 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Mucositis/stomatitis (functional/symp) - Oral cav | 4 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Conduction abnormality - Asystole | 0 Participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 10 Participants |
Overall Survival (OS) of EGFR FISH-positive Patients
From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years
Population: Eligible and evaluable participants who were EGFR-FISH positive
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Chemo +/- Bevacizumab) | Overall Survival (OS) of EGFR FISH-positive Patients | 9.8 Months |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Overall Survival (OS) of EGFR FISH-positive Patients | 13.4 Months |
Progression-Free Survival (PFS) of EGFR FISH-positive Patients by Centralized Review
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression.
Population: Data are not available for this outcome as central image review was not performed. The study was closed for futility at the interim analysis and therefore there was no need to confirm PFS by central review.
Progression-Free Survival (PFS) of the Entire Study Population by Centralized Review
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression.
Population: Data are not available for this outcome as central image review was not performed. The study was closed for futility at the interim analysis and therefore there was no need to confirm PFS by central review.
Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review
From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression.
Population: Eligible and evaluable participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Chemo +/- Bevacizumab) | Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review | 4.5 Months |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review | 4.6 Months |
Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.
Population: Eligible EGFR FISH positive patients with baseline measurable disease are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Chemo +/- Bevacizumab) | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients | 43 percentage of analyzed participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients | 47 percentage of analyzed participants |
Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.
Population: Eligible patients with baseline measurable disease are included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Chemo +/- Bevacizumab) | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population | 36 percentage of analyzed participants |
| Arm II (Chemo, Cetuximab, +/- Bevacizumab) | Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population | 42 percentage of analyzed participants |