Phase 3
N=1,873
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Fallopian Tube Clear Cell Adenocarcinoma · Fallopian Tube Endometrioid Adenocarcinoma · Fallopian Tube Mucinous Adenocarcinoma · Fallopian Tube Serous Adenocarcinoma · Fallopian Tube Transitional Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00262847 ↗Enrolled (actual)
1,873
Serious AEs
42.0%
Results posted
Sep 2013
Primary outcome: Primary: Progression-free Survival — 11.0; 12.3; 15.3 months — p=0.448
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab (Biological); Carboplatin (Drug); Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Placebo (Other); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
11.0; 12.3; 15.3 | 0.448 |
| SECONDARY Overall Survival |
40.6; 38.7; 43.8 | 0.410 |
| SECONDARY Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 |
317; 328; 327; 540; 543; 536 | — |
| SECONDARY Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) |
68.2; 68.0; 67.4; 73.8; 71.1; 70.9 | — |
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.
Eligibility Criteria
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 = 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 inj
Data sourced from ClinicalTrials.gov (NCT00262847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.