Phase 2
Completed N=189
A Study of First Line Treatment With Avastin (Bevacizumab) in Combination With Carboplatin and Weekly Paclitaxel in Patients With Ovarian Cancer
Source: ClinicalTrials.gov NCT00937560 ↗Enrolled (actual)
189
Serious AEs
22.8%
Results posted
Feb 2015
Primary outcomePrimary: Progression-free Survival — 23.7 Months
Summary
This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
23.7 | — |
| SECONDARY Percentage of Participants With an Objective Response |
84.6; 97.0; 92.1 | — |
| SECONDARY Duration of Response |
14.7; 17.5; 17.4 | — |
| SECONDARY Overall Survival at 1 Year and 2 Years |
97.7; 92.1 | — |
| SECONDARY Biological Progression-free Interval |
NA | — |
Eligibility Criteria
Inclusion Criteria
- Female patients, ≥ 18 years of age.
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Initial surgery, but no chemotherapy or radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria
- Non-epithelial tumors.
- Ovarian tumors with low malignant potential.
- Previous systemic anti-cancer therapy for ovarian cancer.
- History or evidence of synchronous primary endometrial cancer.
- Current or recent daily treatment with aspirin (> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.
Data sourced from ClinicalTrials.gov (NCT00937560). 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. Informational only — not medical advice.