Phase 3
N=1,560
Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal 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: NCT00951496 ↗Enrolled (actual)
1,560
Serious AEs
36.0%
Results posted
May 2018
Primary outcome: Primary: Median Progression-free Survival — 24.9; 27.3; 26.0 months — p=0.341
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bevacizumab (Biological); Carboplatin (Drug); Cisplatin (Drug); Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression-free Survival |
24.9; 27.3; 26.0 | 0.341 |
| SECONDARY Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0 |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Overall Survival |
75.4; 74.2; 67.6 | — |
| SECONDARY Patient Reported Quality of Life (QOL) |
68.5; 67.4; 67.7; 67.8; 65.6; 61.9 | — |
| SECONDARY Patient Reported Neurotoxicity (Ntx) |
15.4; 15.4; 15.4; 12.9; 13.0; 13.6 | — |
| SECONDARY Patient Reported Fatigue |
35.3; 35.1; 35.3; 32.5; 32.0; 31.3 | — |
| SECONDARY Patient Reported Nausea |
0.4; 0.4; 0.4; 0.6; 0.7; 1.1 | — |
Summary
This randomized phase III trial studies bevacizumab and intravenous (given into a vein) chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Eligibility Criteria
Inclusion Criteria
- Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage II, III, or IV with either optimal (= 150 mm Hg or diastolic > 90 mmHg
- 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, or past history of supraventricular tachycardia controlled with medications and that is asymptomatic (03/29/10)
- CTCAE grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit)
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies; patients with known allergy to Cremophor or polysorbate 80
- Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); 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 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
- Core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle 2)
- Patients with GOG performance grade of 3 or 4
- Patients who are pregnant or nursing; 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/ or those who require parenteral hydration and/or nutrition; patients with history or current diagnosis of inflammatory bowel disease are not eligible (12/20/10)
- Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; examples of this would be: persistent gastrointestinal symptoms resulting from clostridia difficile enterocolitis or bowel surgery which may increase gastrointestinal toxicity from bevacizumab; or hearing loss or neuropathy which would prevent tolerance to cisplatin, and paclitaxel administration; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regard (12/20/10)
- Patients with metastatic tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patient as high risk of lethal hemorrhage during treatment with bevacizumab (i.e. hemoptysis, liver rupture) (11/02/2009)
Data sourced from ClinicalTrials.gov (NCT00951496). 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.