Phase 3
N=484
A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00434642 ↗Enrolled (actual)
484
Serious AEs
31.0%
Results posted
Nov 2011
Primary outcome: Primary: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) — 12.4; 8.4 Months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Carboplatin (Drug); Gemcitabine (Drug); Bevacizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Genentech, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) |
12.4; 8.4 | <0.0001 sig |
| SECONDARY Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) |
78.5; 57.4 | <0.0001 sig |
| SECONDARY Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) |
10.4; 7.4 | — |
| SECONDARY Overall Survival |
33.6; 32.9 | 0.6479 |
| SECONDARY Percentage of Patients Who Had a Gastrointestinal Perforation (GIP) |
0; 0 | — |
| SECONDARY Percentage of Patients Who Had at Least 1 Adverse Event |
100.0; 100.0 | — |
Summary
This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form
- Age ≥ 18 years
- Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred
- No prior chemotherapy in the recurrent setting
- Measurable disease
- Recovered from prior radiation therapy or surgery
Exclusion Criteria
- Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma
- History of abdominal fistula, gastrointestinal perforation (GIP), or intra-abdominal abscess
- Patients with clinical symptoms or signs of gastrointestinal (GI) obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding
- Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Current, recent, or planned participation in an experimental drug study
- History of systemic bevacizumab (Avastin) or other vascular endothelial growth factor (VEGF) or VEGF receptor-targeted agent use
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association Class II or greater congestive heart failure (CHF)
- History of myocardial infarction or unstable angina
- History of stroke or transient ischemic attack (TIA)
- Known central nervous system (CNS) disease except for treated brain metastasis
- Significant vascular disease or recent peripheral arterial thrombosis
- History of hemoptysis
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Data sourced from ClinicalTrials.gov (NCT00434642). 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.