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S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer

A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00946712
Enrollment
1333
Registered
2009-07-27
Start date
2009-07-15
Completion date
2022-02-08
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

BIOLOGICALBevacizumab

Given IV

DRUGCarboplatin

Given IV

BIOLOGICALCetuximab

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGPaclitaxel

Given IV

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Overall Survival (OS) in the Entire Study PopulationPatients 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 yearsFrom 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 ReviewDisease 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

MeasureTime frameDescription
Progression-Free Survival (PFS) of the Entire Study Population by Institutional ReviewDisease 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 ReviewDisease 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 PatientsPatients 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 yearsFrom 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 PopulationDisease 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 DrugsToxicity 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 PatientsDisease 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 ReviewDisease 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

ArmCount
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
Total1,313

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event118124
Overall StudyDeath2122
Overall StudyDisease progression308404
Overall StudyIneligible146
Overall StudyNo treatment given2529
Overall StudyOn Treatment04
Overall StudyOther reasons6173

Baseline characteristics

CharacteristicArm I (Chemo +/- Bevacizumab)Arm II (Chemo, Cetuximab, +/- Bevacizumab)Total
Age, Continuous63 years63 years63 years
Age, Customized
Age, Categorized
Age <= 65
379 Participants381 Participants760 Participants
Age, Customized
Age, Categorized
Age > 65
278 Participants275 Participants553 Participants
Bevacizumab treatment
No
380 Participants373 Participants753 Participants
Bevacizumab treatment
Yes
277 Participants283 Participants560 Participants
EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status
Negative
293 Participants283 Participants576 Participants
EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status
Positive
201 Participants199 Participants400 Participants
EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status
Unknown
163 Participants174 Participants337 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
26 Participants16 Participants42 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
606 Participants618 Participants1224 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
25 Participants22 Participants47 Participants
Histology
Adenocarcinoma
408 Participants411 Participants819 Participants
Histology
Other
88 Participants85 Participants173 Participants
Histology
Squamous cell carcinoma
161 Participants160 Participants321 Participants
M-stage
M1a
148 Participants150 Participants298 Participants
M-stage
M1b
509 Participants506 Participants1015 Participants
Performance Status
0
229 Participants256 Participants485 Participants
Performance Status
1
427 Participants400 Participants827 Participants
Performance Status
Missing Data
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Race
Asian
10 Participants18 Participants28 Participants
Race/Ethnicity, Customized
Race
Black
61 Participants55 Participants116 Participants
Race/Ethnicity, Customized
Race
Native American
2 Participants1 Participants3 Participants
Race/Ethnicity, Customized
Race
Pacific Islander
3 Participants6 Participants9 Participants
Race/Ethnicity, Customized
Race
Unknown
16 Participants8 Participants24 Participants
Race/Ethnicity, Customized
Race
White
565 Participants568 Participants1133 Participants
Sex: Female, Male
Female
298 Participants271 Participants569 Participants
Sex: Female, Male
Male
359 Participants385 Participants744 Participants
Smoking History
Current
297 Participants292 Participants589 Participants
Smoking History
Former
303 Participants305 Participants608 Participants
Smoking History
Never
57 Participants59 Participants116 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
593 / 657570 / 656
other
Total, other adverse events
619 / 632611 / 627
serious
Total, serious adverse events
66 / 63297 / 627

Outcome results

Primary

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.

ArmMeasureValue (MEDIAN)
Arm I (Chemo +/- Bevacizumab)Overall Survival (OS) in the Entire Study Population9.2 months
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Overall Survival (OS) in the Entire Study Population10.9 months
p-value: 0.2295% CI: [0.83, 1.04]Log Rank
Primary

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.

ArmMeasureValue (MEDIAN)
Arm I (Chemo +/- Bevacizumab)Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review4.8 months
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review5.4 months
p-value: 0.495% CI: [0.75, 1.12]Log Rank
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNausea26 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNeuroendocrine: ADH secretion abnormality0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNeuropathy: motor18 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNeuropathy: sensory57 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNeutrophils/granulocytes (ANC/AGC)158 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsObstruction, GI - Small bowel NOS0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsObstruction/stenosis of airway - Bronchus1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsOcular/Visual-Other (Specify)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsOpportunistic inf associated w/gt=Gr 2 lymphopenia1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Abdomen NOS5 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Back1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Bone2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Chest wall1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Chest/thorax NOS1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Extremity-limb10 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Head/headache2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Joint19 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Muscle24 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Neck1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Neuralgia/peripheral nerve1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Oral cavity0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Peritoneum1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Scrotum1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Skin0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Stomach0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain-Other (Specify)2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPancreatitis0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPerforation, GI - Colon1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPerforation, GI - Duodenum1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPerforation, GI - Small bowel NOS0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPericardial effusion (non-malignant)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPhosphate, serum-low (hypophosphatemia)2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPlatelets51 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPleural effusion (non-malignant)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPneumonitis/pulmonary infiltrates2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPotassium, serum-high (hyperkalemia)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPotassium, serum-low (hypokalemia)22 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsProteinuria4 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPruritus/itching0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPulmonary/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 DrugsRash/desquamation1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRash: acne/acneiform0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRash: hand-foot skin reaction0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRenal failure0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRenal/Genitourinary-Other (Specify)3 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSVT and nodal arrhythmia - Atrial fibrillation2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSVT and nodal arrhythmia - Atrial flutter1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSVT and nodal arrhythmia - SVT tachycardia1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSVT and nodal arrhythmia - Sinus tachycardia1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSeizure0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSodium, serum-low (hyponatremia)29 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSomnolence/depressed level of consciousness1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSudden death0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSyncope (fainting)8 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSyndromes-Other (Specify)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsThrombosis/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 DrugsThrombosis/thrombus/embolism26 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTinnitus0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTremor0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTumor lysis syndrome0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTyphlitis (cecal inflammation)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUlcer, GI - Duodenum1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUlcer, GI - Stomach0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUlceration0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUric 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 DrugsUrticaria (hives, welts, wheals)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsVentricular arrhythmia - Ventricular tachycardia1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsVentricular arrhythmia NOS0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsVisceral 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 DrugsVomiting19 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsWeight gain0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsWeight loss8 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsWound complication, non-infectious0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection 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 DrugsMucositis/stomatitis (clinical exam) - Oral cavity2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsALT, 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 DrugsAST, SGOT6 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAcidosis (metabolic or respiratory)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAdrenal insufficiency0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAlbumin, serum-low (hypoalbuminemia)8 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAlkaline phosphatase2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAllergic reaction/hypersensitivity9 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAllergy/Immunology-Other (Specify)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAnorexia22 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsApnea0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAspiration0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAtaxia (incoordination)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsBilirubin (hyperbilirubinemia)2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsBlood/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 DrugsBronchospasm, wheezing0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCNS cerebrovascular ischemia2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCalcium, serum-high (hypercalcemia)2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCalcium, serum-low (hypocalcemia)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCarbon 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 DrugsCardiac General-Other (Specify)2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCardiac troponin I (cTnI)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCardiac-ischemia/infarction1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCardiopulmonary 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 DrugsCognitive disturbance1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsColitis0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsColitis, 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 DrugsConduction abnormality - Asystole1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsConfusion1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsConstipation4 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCough1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCreatinine0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCytokine release syndrome/acute infusion reaction0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDeath - Multi-organ failure0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDeath not associated with CTCAE term - Death NOS1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDehydration27 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDermatology/Skin-Other (Specify)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDiarrhea15 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDizziness10 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDry eye syndrome0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDry 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 DrugsDry skin0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDysphagia (difficulty swallowing)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDyspnea (shortness of breath)21 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsEdema: limb1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsEncephalopathy1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsEsophagitis0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsExtrapyramidal/involuntary movement/restlessness0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsEyelid dysfunction0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsFatigue (asthenia, lethargy, malaise)74 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsFebrile neutropenia27 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsFever in absence of neutropenia, ANC lt1.0x10e9/L2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGGT (gamma-glutamyl transpeptidase)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGastritis (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 DrugsGastrointestinal-Other (Specify)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGlucose, serum-high (hyperglycemia)20 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGlucose, serum-low (hypoglycemia)2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHeartburn/dyspepsia0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemoglobin60 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemolysis0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Abdomen NOS0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Duodenum1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Esophagus1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Jejunum0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Lower GI NOS1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Upper GI NOS1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Varices (esophageal)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Varices (rectal)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, pulmo/upper resp- Bronchopulmonary NOS1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, pulmonary/upper respiratory - Lung1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, pulmonary/upper respiratory - Nose2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, pulmonary/upper respiratory - Pleura1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage/Bleeding-Other (Specify)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHiccoughs (hiccups, singultus)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHot flashes/flushes1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHypertension28 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHypotension5 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHypoxia2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsINR (of prothrombin time)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Blood8 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Bronchus1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Colon1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Duodenum0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Esophagus0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Lung9 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Pleura1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Skin1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - UTI1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Bladder0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Blood2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Catheter1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Dental1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Joint1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Lung11 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Mucosa1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Pelvis0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Perit cav1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Pleura0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Skin0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - UTI1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Blood1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Eye NOS0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Sinus2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection 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 DrugsInfection with unknown ANC - Upper airway NOS0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Urinary tract NOS2 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Wound0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection-Other (Specify)4 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInsomnia1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsIrregular 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 DrugsLeukocytes (total WBC)74 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsLeukoencephalopathy (radiolographic findings)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsLocal complication - device/prosthesis-related0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsLymphopenia39 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMagnesium, serum-high (hypermagnesemia)0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMagnesium, serum-low (hypomagnesemia)6 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMemory impairment0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMental status0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMetabolic/Laboratory-Other (Specify)1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMood alteration - anxiety0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMood alteration - depression3 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMucositis/stomatitis (clinical exam) - Esophagus1 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMucositis/stomatitis (functional/symp) - Oral cav0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMuscle weakness, not d/t neuropathy - Extrem-lower6 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMuscle weakness, not d/t neuropathy - Extrem-upper0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMuscle weakness, not d/t neuropathy - Pelvic0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMuscle weakness, not d/t neuropathy - body/general21 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNail changes0 Participants
Arm I (Chemo +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNasal cavity/paranasal sinus reactions0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsConfusion4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNausea30 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection 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 DrugsNeuroendocrine: ADH secretion abnormality2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsConstipation4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNeuropathy: motor10 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Bronchus0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNeuropathy: sensory36 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCough2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNeutrophils/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 DrugsMemory impairment1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsObstruction, GI - Small bowel NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCreatinine1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsObstruction/stenosis of airway - Bronchus0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsOcular/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 DrugsCytokine release syndrome/acute infusion reaction10 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsOpportunistic inf associated w/gt=Gr 2 lymphopenia0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Upper airway NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Abdomen NOS9 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Chest wall2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDeath - Multi-organ failure2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Back2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Colon0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Bone1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDeath not associated with CTCAE term - Death NOS7 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNail changes4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Chest/thorax NOS2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDehydration31 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Extremity-limb12 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Duodenum1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Head/headache1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDermatology/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 DrugsPain - Joint19 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Urinary tract NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Muscle14 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDiarrhea19 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Neck0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Esophagus1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Neuralgia/peripheral nerve1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDizziness7 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Oral cavity1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMental status1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Peritoneum0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDry eye syndrome1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Scrotum0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Lung7 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain - Skin1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDry 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 DrugsPain - Stomach1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Wound1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPain-Other (Specify)3 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDry skin6 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPancreatitis1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPerforation, GI - Colon6 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDysphagia (difficulty swallowing)2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPerforation, GI - Duodenum0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMuscle weakness, not d/t neuropathy - Extrem-lower9 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPerforation, GI - Small bowel NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsDyspnea (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 DrugsPericardial 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 DrugsInf (clin/microbio) w/Gr 3-4 neuts - Pleura0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPhosphate, 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 DrugsEdema: limb3 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPlatelets43 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection-Other (Specify)2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPleural 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 DrugsEncephalopathy0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPneumonitis/pulmonary infiltrates8 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Skin2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPotassium, 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 DrugsEsophagitis2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPotassium, 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 DrugsMetabolic/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 DrugsProteinuria7 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsExtrapyramidal/involuntary movement/restlessness1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPruritus/itching7 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - UTI2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsPulmonary/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 DrugsEyelid dysfunction1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRash/desquamation6 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInsomnia5 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRash: acne/acneiform50 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsFatigue (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 DrugsRash: hand-foot skin reaction4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Bladder1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRenal failure2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsFebrile neutropenia29 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsRenal/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 DrugsMuscle weakness, not d/t neuropathy - body/general33 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSVT and nodal arrhythmia - Atrial fibrillation0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsFever in absence of neutropenia, ANC lt1.0x10e9/L0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSVT and nodal arrhythmia - Atrial flutter1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Blood4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSVT and nodal arrhythmia - SVT tachycardia1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGGT (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 DrugsSVT and nodal arrhythmia - Sinus tachycardia0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsIrregular 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 DrugsSeizure2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGastritis (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 DrugsSodium, 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 DrugsInf w/normal ANC or Gr 1-2 neutrophils - Catheter0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSomnolence/depressed level of consciousness2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGastrointestinal-Other (Specify)3 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSudden death1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMood alteration - anxiety1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsSyncope (fainting)7 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsGlucose, 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 DrugsSyndromes-Other (Specify)2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Dental0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsThrombosis/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 DrugsGlucose, 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 DrugsThrombosis/thrombus/embolism37 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsLeukocytes (total WBC)103 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTinnitus1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHeartburn/dyspepsia1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTremor1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Joint0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTumor lysis syndrome1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemoglobin48 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsTyphlitis (cecal inflammation)0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMuscle weakness, not d/t neuropathy - Extrem-upper1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUlcer, GI - Duodenum1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemolysis3 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUlcer, GI - Stomach1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Lung8 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUlceration1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Abdomen NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUric 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 DrugsLeukoencephalopathy (radiolographic findings)0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsUrticaria (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 DrugsHemorrhage, GI - Duodenum1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsVentricular arrhythmia - Ventricular tachycardia0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Mucosa0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsVentricular arrhythmia NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Esophagus0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsVisceral 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 DrugsMood alteration - depression2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsVomiting18 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Jejunum1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsWeight gain1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Pelvis1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsWeight loss4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Lower GI NOS0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsWound complication, non-infectious1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsLocal complication - device/prosthesis-related1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection 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 DrugsMucositis/stomatitis (clinical exam) - Esophagus0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, GI - Upper GI NOS2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Perit cav0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsALT, 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 DrugsHemorrhage, 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 DrugsAST, SGOT8 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsNasal cavity/paranasal sinus reactions1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAcidosis (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 DrugsHemorrhage, 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 DrugsAdrenal insufficiency1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - Pleura1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAlbumin, 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 DrugsHemorrhage, pulmo/upper resp- Bronchopulmonary NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAlkaline phosphatase1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsLymphopenia60 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAllergic reaction/hypersensitivity41 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, pulmonary/upper respiratory - Lung3 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAllergy/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 DrugsInf w/normal ANC or Gr 1-2 neutrophils - Skin5 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAnorexia25 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, pulmonary/upper respiratory - Nose1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsApnea1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMucositis/stomatitis (clinical exam) - Oral cavity6 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAspiration2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage, pulmonary/upper respiratory - Pleura0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsAtaxia (incoordination)0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf w/normal ANC or Gr 1-2 neutrophils - UTI0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsBilirubin (hyperbilirubinemia)0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHemorrhage/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 DrugsBlood/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 DrugsMagnesium, 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 DrugsBronchospasm, wheezing2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsHiccoughs (hiccups, singultus)1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCNS cerebrovascular ischemia4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Blood1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCalcium, 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 DrugsHot flashes/flushes1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCalcium, 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 DrugsMuscle weakness, not d/t neuropathy - Pelvic1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCarbon 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 DrugsHypertension17 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCardiac 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 DrugsInfection with unknown ANC - Eye NOS1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCardiac 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 DrugsHypotension11 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCardiac-ischemia/infarction1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsMagnesium, 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 DrugsCardiopulmonary 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 DrugsHypoxia6 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsCognitive disturbance1 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInfection with unknown ANC - Sinus0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsColitis2 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsINR (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 DrugsColitis, 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 DrugsMucositis/stomatitis (functional/symp) - Oral cav4 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsConduction abnormality - Asystole0 Participants
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study DrugsInf (clin/microbio) w/Gr 3-4 neuts - Blood10 Participants
Secondary

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

ArmMeasureValue (MEDIAN)
Arm I (Chemo +/- Bevacizumab)Overall Survival (OS) of EGFR FISH-positive Patients9.8 Months
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Overall Survival (OS) of EGFR FISH-positive Patients13.4 Months
p-value: 0.05495% CI: [0.66, 1]Log Rank
Secondary

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.

Secondary

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.

Secondary

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

ArmMeasureValue (MEDIAN)
Arm I (Chemo +/- Bevacizumab)Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review4.5 Months
Arm II (Chemo, Cetuximab, +/- Bevacizumab)Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review4.6 Months
p-value: 0.8395% CI: [0.88, 1.1]Log Rank
Secondary

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.

ArmMeasureValue (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 Patients43 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 Patients47 percentage of analyzed participants
p-value: 0.48Cochran-Mantel-Haenszel
Secondary

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.

ArmMeasureValue (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 Population36 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 Population42 percentage of analyzed participants
p-value: 0.06Cochran-Mantel-Haenszel

Source: ClinicalTrials.gov · Data processed: May 29, 2026