Borderline Ovarian Mucinous Tumor, Ovarian Mucinous Cystadenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IA Ovarian Cancer AJCC v6 and v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7, Stage IB Ovarian Cancer AJCC v6 and v7, Stage IC Fallopian Tube Cancer AJCC v6 and v7, Stage IC Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Ovarian Cancer AJCC v6 and v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7
Conditions
Brief summary
This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.
Detailed description
PRIMARY OBJECTIVES: I. To determine if capecitabine and oxaliplatin reduces the death rate compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube. II. To determine if bevacizumab reduces the death rate compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube. SECONDARY OBJECTIVES: I. To determine if capecitabine and oxaliplatin increases the duration of progression-free survival (PFS) compared to carboplatin and paclitaxel in women with mucinous adenocarcinoma of the ovary or fallopian tube. II. To determine if bevacizumab increases the duration of PFS compared to no bevacizumab in women with mucinous adenocarcinoma of the ovary or fallopian tube. III. To compare the response rates for capecitabine and oxaliplatin versus carboplatin and paclitaxel in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery. IV. To compare the response rates for bevacizumab versus no bevacizumab in patients with mucinous adenocarcinoma of the ovary or fallopian tube with measurable disease after initial tumor reductive surgery. V. To determine the nature and degree of toxicity of capecitabine and oxaliplatin compared with that of carboplatin and paclitaxel in this cohort of patients. VI. To determine the nature and degree of toxicity of bevacizumab in this cohort of patients. VII. To compare capecitabine and oxaliplatin versus carboplatin and paclitaxel with respect to changes in patient reported neurotoxicity. VIII. To determine the impact on quality of life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian \[FACT-O\] Trial Outcome Index \[TOI\]) following treatment with the above regimens. TERTIARY OBJECTIVES: I. To collect fixed and/or frozen tissue and whole blood for future research studies. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive carboplatin intravenously (IV) over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. ARM IV: Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III. After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
Interventions
Given IV
Given PO
Given IV
Correlative studies
Given IV
Given IV
Ancillary studies
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with a histologic diagnosis of mucinous adenocarcinoma of the ovary or fallopian tube with either optimal (=\< 1 cm residual disease) or suboptimal residual disease following initial surgery; patients may have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or no measurable disease * All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage * Patients must have stage II-IV disease (new or recurrent-chemonaïve; no brain metastasis) or recurrent stage I disease (chemonaïve) * Newly diagnosed patients must begin protocol therapy within 10 weeks of primary debulking; for stage I recurrent patients (chemonaïve), they should begin protocol therapy within 14 days of randomization * Patients must have a negative colonoscopy within 1 year of enrolling in the study * Absolute neutrophil count (ANC) \>= 1,500/mcl * White blood cell (WBC) count \>= 3,000/mcl * Platelets \>= 100,000/mcl * Hemoglobin (Hgb) \>= 10 g/dl (can be post transfusion) * Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance \> 50 cc/min * Bilirubin =\< 1.5 x ULN * Serum glutamic oxaloacetic transaminase (SGOT) =\< to 2.5 x ULN * Alkaline phosphatase =\< to 2.5 x ULN * Neuropathy (sensory and motor) =\< Common Terminology Criteria for Adverse Events (CTCAE) grade 1 * Urine dipstick for proteinuria \< 2+; if urine dipstick is \>= 2+, 24 hour urine must demonstrate =\< 1 g protein in 24 hours OR patients must have a urine protein-to-creatinine ratio (UPCR) \< 1.0 mg/dL * Prothrombin time (PT) =\< 1.5 x ULN * Activated prothrombin time (APTT) =\< 1.5 x ULN * Patients of childbearing potential must agree to practice an effective form of birth control during study treatment and for six months after completion of treatment * Patients who have met the pre-entry requirements * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients with Gynecologic Oncology Group (GOG) performance grade of 0, 1 or 2 * Patients with life expectancy \> 3 months
Exclusion criteria
* Patients with known colon cancer or history of colon cancer * Patients with primary peritoneal carcinoma * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients who have received chemotherapy, radiotherapy or any investigational treatment for a gynecologic cancer (does include breast cancer) or colorectal cancer prior to enrollment * Patients with a major surgical procedure anticipated during the course of the study; this includes but is not limited to: abdominal surgery (laparotomy or laparoscopy) such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures * Patients may have minor surgical procedures (i.e., mediport insertion) fine needle aspiration or core biopsies as long as it is performed \> 7 days prior to the first date of bevacizumab therapy and there is no evidence of wound disruption or impaired healing * Patients with surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for fact that bevacizumab can be omitted from first cycle of chemotherapy) * Patients with a history of abdominal fistula or perforation within the past 12 months * Patients with a current, serious, non-healing wound, ulcer, or bone fracture; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations * Patients with known hypersensitivity to Chinese hamster cell products or other recombinant human or humanized antibodies * Patients with mixed epithelial ovarian cancer histology * Patients with tumors of low malignant potential * History or evidence of upon physical examination of central nervous system (CNS) disease, including history of primary brain tumor or any history of brain metastases, or seizures not controlled with standard medical therapy * Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 100 mm Hg; patients with a history of hypertension are permitted * Myocardial infarction or unstable angina within 12 months of the first date of bevacizumab therapy * New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication; women who have received prior treatment with anthracycline (including doxorubicin and/or liposomal doxorubicin) and have an ejection fraction \< 50% will be excluded from the study * Grade 1, category 2 or greater, peripheral vascular disease; patient cannot have anything worse than mild, symptomatic claudication with exercise * History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of bevacizumab therapy * History of pulmonary embolism or deep vein thrombosis in the past 6 months * Previous history of malabsorption or other conditions preventing oral treatment * Patients who are pregnant or nursing * Patients with acute hepatitis or active infection that requires parenteral antibiotics * Patients with active bleeding or pathologic conditions that carry a high risk of bleeding such as a known bleeding disorder, coagulopathy or tumor involving the major vessels * Patients taking warfarin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to five years | Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Every cycle while on treatment, up to 5 years | Grade 1 or higher non-serious adverse events were graded by CTC AE v 4. |
| Progression-free Survival | Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years. | Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) 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. |
| Objective Tumor Response | CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years | Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: 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 |
| Patient Reported Neurotoxicity | baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5 | Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. |
| Patient Reported Quality of Life | baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5 | Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL |
Countries
United States
Contacts
NRG Oncology
Participant flow
Recruitment details
The study was activated on 12 October 2010 and closed to patient accrual on 28 October 2013.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Carboplatin and Paclitaxel) Patients receive carboplatin IV over 30-60 minutes on day 1 and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies | 13 |
| Arm II (Oxaliplatin and Capecitabine) Patients receive oxaliplatin IV over 2-6 hours on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies | 13 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) Patients receive carboplatin and paclitaxel IV as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes alone on day 1. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Bevacizumab: Given IV
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
Quality-of-Life Assessment: Ancillary studies | 13 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) Patients receive oxaliplatin and capecitabine as in arm II, and bevacizumab as in arm III.
Bevacizumab: Given IV
Capecitabine: Given PO
Laboratory Biomarker Analysis: Correlative studies
Oxaliplatin: Given IV
Quality-of-Life Assessment: Ancillary studies | 11 |
| Total | 50 |
Baseline characteristics
| Characteristic | Arm I (Carboplatin and Paclitaxel) | Arm II (Oxaliplatin and Capecitabine) | Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Total |
|---|---|---|---|---|---|
| Age, Customized 20-29 years | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Age, Customized 30-39 years | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 9 Participants |
| Age, Customized 40-49 years | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 7 Participants |
| Age, Customized 50-59 years | 3 Participants | 7 Participants | 5 Participants | 3 Participants | 18 Participants |
| Age, Customized 60-69 years | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants |
| Age, Customized 70-79 years | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Age, Customized 80-89 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 13 Participants | 11 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| other Total, other adverse events | 13 / 13 | 13 / 13 | 13 / 13 | 11 / 11 |
| serious Total, serious adverse events | 3 / 13 | 4 / 13 | 2 / 13 | 3 / 11 |
Outcome results
Overall Survival
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
Time frame: Up to five years
Population: All randomized patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | Overall Survival | 37.6 months |
| Arm II (Oxaliplatin and Capecitabine) | Overall Survival | 27.8 months |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Overall Survival | 27.7 months |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Overall Survival | 55.7 months |
Objective Tumor Response
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by MRI: 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: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression, and any other time clinically indicated, up to 5 years
Population: All randomized patients with measurable disease
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | Objective Tumor Response | 22 Percentage of Participants |
| Arm II (Oxaliplatin and Capecitabine) | Objective Tumor Response | 27 Percentage of Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Objective Tumor Response | 43 Percentage of Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Objective Tumor Response | 40 Percentage of Participants |
Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0
Grade 1 or higher non-serious adverse events were graded by CTC AE v 4.
Time frame: Every cycle while on treatment, up to 5 years
Population: Eligible and treated patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Gain | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Anemia | 12 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Neutrophils | 7 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low platelets | 8 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Vaginal Bleeding | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low white Blood Cells | 5 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised Blood Counts | 1 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Mucositis | 1 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Bleeding | 1 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Nausea/Vomiting | 8 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Constipation | 3 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Oral Problems | 3 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pneumothorax | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other | 4 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Loss | 2 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other GI Problems | 8 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Cold-like symptoms | 2 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pain | 9 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Peripheral/Sensory Neuropathy | 11 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Rash | 4 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | dyspnea | 2 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fever | 3 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Edema Limbs | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised CA19-9 | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fatigue | 10 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic rhinitis | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hand/Foot Syndrome | 1 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Stomatitis | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Headache | 3 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypertension | 3 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic reaction | 3 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Taste Alteration | 3 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypomagnesemia | 1 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Alopecia | 11 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Infection | 4 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Laryngeal Spasm | 0 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Diarrhea | 5 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Urinary Problems | 1 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Lymphocytes | 1 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Abnormal lab values | 8 Participants |
| Arm I (Carboplatin and Paclitaxel) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Mood | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypertension | 8 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | dyspnea | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Rash | 2 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Neutrophils | 5 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Diarrhea | 6 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Anemia | 7 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Alopecia | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low platelets | 3 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Mood | 2 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Vaginal Bleeding | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Edema Limbs | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low white Blood Cells | 5 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Laryngeal Spasm | 4 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Abnormal lab values | 10 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fever | 0 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Mucositis | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised Blood Counts | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypomagnesemia | 0 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fatigue | 10 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Nausea/Vomiting | 8 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Taste Alteration | 2 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Bleeding | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Lymphocytes | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Oral Problems | 2 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Gain | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hand/Foot Syndrome | 0 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Urinary Problems | 0 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other | 4 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic reaction | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic rhinitis | 1 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Infection | 0 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other GI Problems | 6 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Loss | 3 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Headache | 4 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Stomatitis | 2 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pain | 6 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Constipation | 4 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Cold-like symptoms | 3 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised CA19-9 | 0 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Peripheral/Sensory Neuropathy | 11 Participants |
| Arm II (Oxaliplatin and Capecitabine) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pneumothorax | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Peripheral/Sensory Neuropathy | 8 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pneumothorax | 0 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised CA19-9 | 2 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised Blood Counts | 0 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Rash | 3 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Constipation | 7 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Stomatitis | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Taste Alteration | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Urinary Problems | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Vaginal Bleeding | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Diarrhea | 5 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Gain | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Loss | 4 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fatigue | 8 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | dyspnea | 3 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic reaction | 0 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Edema Limbs | 0 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hand/Foot Syndrome | 0 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Headache | 5 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic rhinitis | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypertension | 9 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fever | 2 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypomagnesemia | 2 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Infection | 3 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Laryngeal Spasm | 0 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Alopecia | 9 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Lymphocytes | 2 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Mood | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Neutrophils | 4 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low platelets | 5 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Anemia | 4 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low white Blood Cells | 4 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Mucositis | 1 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Nausea/Vomiting | 9 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Oral Problems | 4 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Bleeding | 3 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other | 7 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Abnormal lab values | 10 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other GI Problems | 7 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pain | 7 Participants |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Cold-like symptoms | 7 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Loss | 5 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fatigue | 11 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Abnormal lab values | 10 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic reaction | 4 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Allergic rhinitis | 1 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Alopecia | 5 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Anemia | 6 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Bleeding | 5 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Cold-like symptoms | 6 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Constipation | 9 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Diarrhea | 8 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | dyspnea | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Edema Limbs | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Fever | 1 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hand/Foot Syndrome | 7 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Headache | 4 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypertension | 10 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Hypomagnesemia | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Infection | 3 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Laryngeal Spasm | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Lymphocytes | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Mood | 1 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low Neutrophils | 7 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low platelets | 7 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Low white Blood Cells | 6 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Mucositis | 3 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Nausea/Vomiting | 9 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Oral Problems | 9 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other | 7 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Other GI Problems | 6 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pain | 7 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Peripheral/Sensory Neuropathy | 10 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Pneumothorax | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised CA19-9 | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Raised Blood Counts | 1 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Rash | 4 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Stomatitis | 0 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Taste Alteration | 2 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Urinary Problems | 2 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Vaginal Bleeding | 2 Participants |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Participants With Grade 1 or Higher Non-serious Adverse Effects Assessed by CTCAE Version 4.0 | Weight Gain | 2 Participants |
Patient Reported Neurotoxicity
Patient reported neurotoxicity symptoms as measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity.
Time frame: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Population: Patients who provided a valid FACT/GOG-Ntx subscale assessment. Data were not collected at certain time points for certain arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | Post cycle 6 | 6.5 units on a scale. | Standard Deviation 2.1 |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | 2 years after BEV | 8.0 units on a scale. | — |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | End of bevacizumab (BEV) | 16.0 units on a scale. | — |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | Six months post chemo | 5.0 units on a scale. | Standard Deviation 4.2 |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | Pre-cycle 4 | 7.3 units on a scale. | Standard Deviation 4.2 |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | 3 years after BEV | 14.0 units on a scale. | — |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | Six months after BEV | 10.0 units on a scale. | — |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Neurotoxicity | Baseline (pre-treatment) | 16.0 units on a scale. | Standard Deviation 0 |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Neurotoxicity | End of bevacizumab (BEV) | 10.0 units on a scale. | — |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Neurotoxicity | Baseline (pre-treatment) | 15.3 units on a scale. | Standard Deviation 1.2 |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Neurotoxicity | Pre-cycle 4 | 11.8 units on a scale. | Standard Deviation 5.3 |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Neurotoxicity | Post cycle 6 | 11.7 units on a scale. | Standard Deviation 4 |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Neurotoxicity | Six months after BEV | 10.0 units on a scale. | — |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Neurotoxicity | 2 years after BEV | 14.0 units on a scale. | — |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | 5 years after BEV | 7.5 units on a scale. | Standard Deviation 3.5 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | 2 years after BEV | 5.5 units on a scale. | Standard Deviation 4.9 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | Pre-cycle 4 | 12.7 units on a scale. | Standard Deviation 3.5 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | Baseline (pre-treatment) | 14.3 units on a scale. | Standard Deviation 2.9 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | 3 years after BEV | 9.5 units on a scale. | Standard Deviation 4.9 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | 4 years after BEV | 6.5 units on a scale. | Standard Deviation 6.4 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | Six months after BEV | 9.0 units on a scale. | Standard Deviation 4.2 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | Six months post chemo | 11.3 units on a scale. | Standard Deviation 5.7 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | End of bevacizumab (BEV) | 9.5 units on a scale. | Standard Deviation 4.9 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Neurotoxicity | Post cycle 6 | 11.0 units on a scale. | Standard Deviation 5.6 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | Baseline (pre-treatment) | 16.0 units on a scale. | Standard Deviation 0 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | Pre-cycle 4 | 5.7 units on a scale. | Standard Deviation 4.9 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | End of bevacizumab (BEV) | 11.7 units on a scale. | Standard Deviation 3.8 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | Six months after BEV | 7.0 units on a scale. | Standard Deviation 9.9 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | Six months post chemo | 10.7 units on a scale. | Standard Deviation 2.3 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | 2 years after BEV | 16.0 units on a scale. | — |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | 3 years after BEV | 16.0 units on a scale. | — |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Neurotoxicity | Post cycle 6 | 8.0 units on a scale. | Standard Deviation 6.3 |
Patient Reported Quality of Life
Patient reported quality of life was measured with the Treatment Outcome Index of the Functional Assessment of Cancer Therapy for endometrial cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. The FACT-O TOI score ranges 0-100 with a large score suggests better QOL
Time frame: baseline (pre-treatment), pre cycle 4, post cycle 6, six months post-chemo, end of bevacizumab [BEV] (or 39 weeks after completion of chemotherapy in the non-BEV arms or in those who discontinue BEV), six months after BEV, and years 2, 3, 4, and 5
Population: All Randomized Patients with at least one post-baseline QOL assessment reported were averaged. Data were not collected at certain time points for certain arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | End of Bevacizumab (BEV) | 68.9 units on a scale | — |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | Post-Cycle 6 | 65.2 units on a scale | Standard Deviation 4 |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | 3 Years after BEV | 76.4 units on a scale | — |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | Six Months Post-Chemo | 74.1 units on a scale | Standard Deviation 14.2 |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | 2 Years after BEV | 71.7 units on a scale | — |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | Pre-Cycle 4 | 57.5 units on a scale | Standard Deviation 4.8 |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | Baseline (pre-treatment) | 62.6 units on a scale | Standard Deviation 12.6 |
| Arm I (Carboplatin and Paclitaxel) | Patient Reported Quality of Life | Six Months after BEV | 54.0 units on a scale | — |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Quality of Life | Six Months after BEV | 53.0 units on a scale | — |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Quality of Life | Baseline (pre-treatment) | 62.3 units on a scale | Standard Deviation 29.5 |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Quality of Life | Pre-Cycle 4 | 72.9 units on a scale | Standard Deviation 16.4 |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Quality of Life | Post-Cycle 6 | 73.5 units on a scale | Standard Deviation 9.1 |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Quality of Life | End of Bevacizumab (BEV) | 53.3 units on a scale | — |
| Arm II (Oxaliplatin and Capecitabine) | Patient Reported Quality of Life | 2 Years after BEV | 56.0 units on a scale | — |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | Six Months Post-Chemo | 80.3 units on a scale | Standard Deviation 12.2 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | End of Bevacizumab (BEV) | 73.0 units on a scale | Standard Deviation 22.6 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | Pre-Cycle 4 | 68.7 units on a scale | Standard Deviation 2.1 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | Six Months after BEV | 87.5 units on a scale | Standard Deviation 7.8 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | 5 Years after BEV | 78.0 units on a scale | Standard Deviation 17 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | 2 Years after BEV | 76.3 units on a scale | Standard Deviation 15.2 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | Baseline (pre-treatment) | 68.7 units on a scale | Standard Deviation 9.7 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | 3 Years after BEV | 80.5 units on a scale | Standard Deviation 17.7 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | Post-Cycle 6 | 68.3 units on a scale | Standard Deviation 5.5 |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Patient Reported Quality of Life | 4 Years after BEV | 71.5 units on a scale | Standard Deviation 24.7 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | Six Months Post-Chemo | 68.7 units on a scale | Standard Deviation 29.7 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | Pre-Cycle 4 | 76.0 units on a scale | Standard Deviation 12.5 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | Baseline (pre-treatment) | 75.4 units on a scale | Standard Deviation 15.9 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | 3 Years after BEV | 76.0 units on a scale | — |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | End of Bevacizumab (BEV) | 49.9 units on a scale | Standard Deviation 31.4 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | Post-Cycle 6 | 71.8 units on a scale | Standard Deviation 14.1 |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | 2 Years after BEV | 77.0 units on a scale | — |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Patient Reported Quality of Life | Six Months after BEV | 70.5 units on a scale | Standard Deviation 26.2 |
Progression-free Survival
Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) 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: Is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
Population: All Randomized Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Carboplatin and Paclitaxel) | Progression-free Survival | 36.1 Months |
| Arm II (Oxaliplatin and Capecitabine) | Progression-free Survival | 7.4 Months |
| Arm III (Carboplatin, Paclitaxel, Bevacizumab) | Progression-free Survival | 15.4 Months |
| Arm IV (Oxaliplatin, Capecitabine, Bevacizumab) | Progression-free Survival | 23.3 Months |
Numbers and Percentages of Patients With Mutations in the Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Oncogene
Will be tabulated. Interactions between the mutational status of the KRAS oncogene and treatment will be examined.
Time frame: Baseline