Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Malignant Ovarian Mixed Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer, Undifferentiated Fallopian Tube Carcinoma, Undifferentiated Ovarian Carcinoma
Conditions
Brief summary
This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. 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 or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Detailed description
PRIMARY OBJECTIVE: I. To determine if the addition of 5 concurrent cycles of bevacizumab to 6 cycles of standard therapy (carboplatin and paclitaxel) (Arm II) increases the duration of progression-free survival (PFS) when compared to 6 cycles of standard therapy alone (Arm I) in women with newly diagnosed stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer. II. To determine if the addition of 5 concurrent cycles of bevacizumab plus extended bevacizumab for 16 cycles beyond the 6 cycles of standard therapy (carboplatin and paclitaxel) (Arm III) increases progression-free survival when compared to 6 cycles of standard therapy (Arm I) in women with newly diagnosed stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer. SECONDARY OBJECTIVES: I. In the event that both Arm II and Arm III regimens are superior to the Arm I regimen with respect to progression-free survival, to determine whether the Arm III regimen prolongs progression-free survival when compared to the Arm II regimen. II. To determine whether the Arm II or Arm III regimen increases the duration of overall survival when compared with the Arm I regimen. III. To compare each of the experimental regimens to the Arm I regimen with respect to the incidence of severe toxicities or serious adverse events. IV. 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 assess the relationship between angiogenic markers and clinical outcome including tumor response, progression-free survival and overall survival in patients randomized to standard cytotoxic chemotherapy (paclitaxel and carboplatin) without bevacizumab, with concurrent bevacizumab or with extended bevacizumab. II. To assess the predictive value of a set of genes whose expression correlates with survival of patients with stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer. III. To bank whole blood for research. IV. To determine if genetic variations in genes associated with essential hypertension including WNK lysine deficient protein kinase 1 (WNK1), G protein-coupled receptor kinase 4 (GRK4) and kallikrein B (KLKB1) predict which patients are likely to develop bevacizumab-induced hypertension. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive bevacizumab alone IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Interventions
Given IV
Given IV
Correlative studies
Given IV
Given IV
Ancillary studies
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer; International Federation of Gynecology and Obstetrics (FIGO) stage III with any gross (macroscopic or palpable) residual disease or FIGO stage IV, defined surgically at the completion of initial abdominal surgery and with appropriate tissue available for histologic evaluation; the minimum surgery required was an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual; however, the surgeon is not required to have performed all of the items contained in this section of the GOG Surgical Procedures Manual; those patients with stage III cancer in which the largest maximal diameter of any residual tumor implant at the completion of this initial surgery is no greater than 1 cm will be defined as optimal; all others will be defined as suboptimal; measurable disease on post-operative imaging studies is not required for eligibility * Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist or, if necessary, the Pathology Co-Chair, prior to entry; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube * Absolute neutrophil count (ANC) greater than or equal to 1,500/µl equivalent to Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors * Platelets greater than or equal to 100,000/µl; (CTCAE grade 0-1) * Creatinine =\< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1 * Bilirubin less than or equal to 1.5 x ULN (CTCAE grade 1) * Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) * Neuropathy (sensory and motor) less than or equal to CTCAE grade 1 * Prothrombin time (PT) such that international normalized ratio (INR) is =\< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thrombo-embolus) and a partial thromboplastin time (PTT) \< 1.2 times the upper limit of normal * Patients with a GOG Performance Status of 0, 1, or 2 * Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction * Patients with measurable and non-measurable disease are eligible; patients may or may not have cancer-related symptoms * Patients who have met the pre-entry requirements * An approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardian * Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not progestins for management of anorexia while on protocol directed therapy or prior to disease progression
Exclusion criteria
* Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential) or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage Ia or Ib low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease * Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian or peritoneal primary cancer * Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions * With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded * Patients with acute hepatitis or active infection that requires parenteral antibiotics * Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; 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 active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels * Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study * Patients with clinically significant cardiovascular disease; this includes: * Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg * Myocardial infarction or unstable angina \< 6 months prior to registration * New York Heart Association (NYHA) grade II or greater congestive heart failure * Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate * CTCAE grade 2 or greater peripheral vascular disease (at least brief (\< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit) * History of CVA within six months * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine); send sample to lab with request for urine protein and creatinine levels \[separate requests\]; the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR \< 1.0 to allow participation in the study * Patients with or with anticipation of invasive procedures as defined below: * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab/placebo therapy (cycle 2) * Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression, 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 * Core biopsy, within 7 days prior to the first date of bevacizumab/placebo therapy (cycle 2) * Patients with GOG Performance Grade of 3 or 4 * Patients who are pregnant or nursing; bevacizumab should not be administered to nursing women; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy * Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab * Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition * Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the study chair or study co-chairs for uncertainty in this regard
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | From study entry until first disease progression, death or date of last contact, up to 6 years | Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From study entry to death or last contact, up to 6 years | Median overall survival (OS) |
| Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Up to 5 years | Eligible and Evaluable patients |
| Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | At baseline, 9, 18, 36, 60, and 84 weeks | Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means. |
Countries
Canada, Japan, South Korea, United States
Participant flow
Recruitment details
Between October 2005 and June 2009, 1873 women were enrolled from 336 institutions in the United States, Canada, South Korea, and Japan.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Placebo, Paclitaxel, Carboplatin) Control therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks. | 625 |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Bevacizumab-initiation therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received placebo every 3 weeks. | 625 |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) Bevacizumab-throughout therapy:
Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.
Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks. | 623 |
| Total | 1,873 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 74 | 88 | 108 |
| Overall Study | Concomitant disease | 3 | 2 | 4 |
| Overall Study | Death | 8 | 8 | 11 |
| Overall Study | Did not receive study treatment | 4 | 1 | 4 |
| Overall Study | Disease Progression | 309 | 274 | 195 |
| Overall Study | Other Reasons | 79 | 88 | 27 |
| Overall Study | Patient Refusal | 41 | 52 | 47 |
Baseline characteristics
| Characteristic | Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Arm I (Placebo, Paclitaxel, Carboplatin) | Total |
|---|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 10.6 | 60.1 years STANDARD_DEVIATION 10.3 | 59.3 years STANDARD_DEVIATION 10.9 | 59.7 years STANDARD_DEVIATION 10.6 |
| Gynecologic Oncology Group (GOG) Performance Status 0 - fully active | 305 participants | 315 participants | 311 participants | 931 participants |
| Gynecologic Oncology Group (GOG) Performance Status 1 - restricted strenuous activity, ambulatory | 267 participants | 270 participants | 272 participants | 809 participants |
| Gynecologic Oncology Group (GOG) Performance Status 2 - ambulatory, difficulty walking | 51 participants | 40 participants | 42 participants | 133 participants |
| Gynecologic Oncology Group (GOG) Performance Status 3 - limited self-care, partly confined to bed | 0 participants | 0 participants | 0 participants | 0 participants |
| Gynecologic Oncology Group (GOG) Performance Status 4 - completely disabled, no self-care | 0 participants | 0 participants | 0 participants | 0 participants |
| Histologic Type Clear cell | 20 participants | 23 participants | 12 participants | 55 participants |
| Histologic Type Endometrioid | 24 participants | 14 participants | 21 participants | 59 participants |
| Histologic Type Mucinous | 8 participants | 5 participants | 6 participants | 19 participants |
| Histologic Type Other or not specified | 47 participants | 64 participants | 45 participants | 156 participants |
| Histologic Type Serous adenocarcinoma | 524 participants | 519 participants | 541 participants | 1584 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 1A-1 ovary involved, no ascites | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 1B-both ovaries involved, no ascites | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 1C-disease with capsules ruptured or ascites | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 1-limited to ovaries | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 2A-disease with extension to uterus and or tubes | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 2B-disease with extension to other pelvic tissues | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 2C-disease with capsules ruptured or ascites | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 2-disease with pelvic extension | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 3A-disease w/ microscopic implants, negative nodes | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 3B-disease w/ abdominal implants <2cm, neg nodes | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 3C-disease w/ abdominal implants >2cm, pos nodes | 0 participants | 0 participants | 0 participants | 0 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 3-disease w/ implants > 1 cm outside pelvis | 242 participants | 256 participants | 254 participants | 752 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 3-disease w/ macroscopic implants outside pelvis | 216 participants | 205 participants | 218 participants | 639 participants |
| International Federation of Gynecologic and Obstetrics (FIGO) Stage 4-distant metastatis | 165 participants | 164 participants | 153 participants | 482 participants |
| Race/Ethnicity, Customized Asian | 39 participant | 37 participant | 41 participant | 117 participant |
| Race/Ethnicity, Customized Hispanic | 25 participant | 28 participant | 21 participant | 74 participant |
| Race/Ethnicity, Customized Non-Hispanic black | 27 participant | 28 participant | 25 participant | 80 participant |
| Race/Ethnicity, Customized Non-Hispanic white | 521 participant | 519 participant | 526 participant | 1566 participant |
| Race/Ethnicity, Customized Other or unspecified | 11 participant | 13 participant | 12 participant | 36 participant |
| Region of Enrollment Canada | 3 participants | 5 participants | 1 participants | 9 participants |
| Region of Enrollment Japan | 12 participants | 12 participants | 21 participants | 45 participants |
| Region of Enrollment Korea, Republic of | 9 participants | 12 participants | 7 participants | 28 participants |
| Region of Enrollment United States | 599 participants | 596 participants | 596 participants | 1791 participants |
| Sex: Female, Male Female | 623 Participants | 625 Participants | 625 Participants | 1873 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Tumor Grade 1 | 18 participants | 28 participants | 36 participants | 82 participants |
| Tumor Grade 2 | 97 participants | 86 participants | 102 participants | 285 participants |
| Tumor Grade 3 | 460 participants | 465 participants | 445 participants | 1370 participants |
| Tumor Grade Not graded | 48 participants | 46 participants | 42 participants | 136 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 589 / 621 | 593 / 624 | 588 / 619 |
| serious Total, serious adverse events | 239 / 621 | 257 / 624 | 287 / 619 |
Outcome results
Progression-free Survival
Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).
Time frame: From study entry until first disease progression, death or date of last contact, up to 6 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Placebo, Paclitaxel, Carboplatin) | Progression-free Survival | 11.0 months |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Progression-free Survival | 12.3 months |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Progression-free Survival | 15.3 months |
Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Eligible and Evaluable patients
Time frame: Up to 5 years
Population: Eligible and evaluable patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 16 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 62 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | White blood cell | 317 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 91 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 13 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 13 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 4 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 4 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Death, not CTC coded | 5 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 75 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 96 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 29 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hepatobiliary | 2 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/Renal | 13 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 23 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 5 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemoglobin | 91 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 74 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Auditory/Ear | 1 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Absolute neutrophil count | 540 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/Visual | 4 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | hypertension | 10 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 37 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 44 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 14 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Platelets | 93 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 23 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 5 Participants |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Sexual/Reproductive | 1 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 36 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | White blood cell | 328 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Absolute neutrophil count | 543 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemoglobin | 86 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Platelets | 122 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 13 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 25 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Auditory/Ear | 1 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | hypertension | 36 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 12 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 7 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 61 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 20 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 4 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 112 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/Renal | 8 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 9 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hepatobiliary | 1 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 73 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 3 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 87 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 17 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 26 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 42 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/Visual | 1 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 82 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 33 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Death, not CTC coded | 8 Participants |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Sexual/Reproductive | 0 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemoglobin | 74 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Metabolic | 101 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Coagulation | 8 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | White blood cell | 327 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Musculoskeletal | 21 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Cardiac | 18 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Vascular | 40 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Neurosensory | 28 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | hypertension | 65 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Absolute neutrophil count | 536 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other neurological | 65 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Auditory/Ear | 2 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Sexual/Reproductive | 0 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Ocular/Visual | 4 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Allergy/Immunology | 14 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Death, not CTC coded | 10 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Genitourinary/Renal | 8 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pain | 101 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hemorrhage | 15 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Gastrointestinal | 122 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Other hematologic | 9 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Hepatobiliary | 3 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Endocrine | 2 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Platelets | 131 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Infection | 95 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Dermatologic | 16 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Pulmonary | 32 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Lymphatics | 3 Participants |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 | Constitutional | 83 Participants |
Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)
Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.
Time frame: At baseline, 9, 18, 36, 60, and 84 weeks
Population: Number of valid QOL assessments do not total number of patients randomized in study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Placebo, Paclitaxel, Carboplatin) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to treatment | 68.2 units on a scale | Standard Deviation 0.64 |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 4 | 73.8 units on a scale | Standard Deviation 0.53 |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 7 | 76.0 units on a scale | Standard Deviation 0.54 |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 13 | 80.6 units on a scale | Standard Deviation 0.62 |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 21 | 77.6 units on a scale | Standard Deviation 0.73 |
| Arm I (Placebo, Paclitaxel, Carboplatin) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | 6 months followup | 75.8 units on a scale | Standard Deviation 0.78 |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | 6 months followup | 77.6 units on a scale | Standard Deviation 0.75 |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to treatment | 68.0 units on a scale | Standard Deviation 0.66 |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 13 | 80.5 units on a scale | Standard Deviation 0.62 |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 21 | 79.1 units on a scale | Standard Deviation 0.71 |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 4 | 71.1 units on a scale | Standard Deviation 0.56 |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 7 | 74.3 units on a scale | Standard Deviation 0.56 |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 4 | 70.9 units on a scale | Standard Deviation 0.54 |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 7 | 73.8 units on a scale | Standard Deviation 0.58 |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | 6 months followup | 77.8 units on a scale | Standard Deviation 0.75 |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 13 | 79.9 units on a scale | Standard Deviation 0.58 |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to treatment | 67.4 units on a scale | Standard Deviation 0.65 |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) | prior to cycle 21 | 78.6 units on a scale | Standard Deviation 0.66 |
Overall Survival
Median overall survival (OS)
Time frame: From study entry to death or last contact, up to 6 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm I (Placebo, Paclitaxel, Carboplatin) | Overall Survival | 40.6 months |
| Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) | Overall Survival | 38.7 months |
| Arm III (Paclitaxel, Carboplatin, Bevacizumab) | Overall Survival | 43.8 months |