Status:
COMPLETED
A Study of the Addition of Avastin (Bevacizumab) to Carboplatin and Paclitaxel Therapy in Patients With Ovarian Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epitheli...
Eligibility Criteria
Inclusion
- Histologically confirmed epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma or clear cell carcinoma or carcinosarcoma. Participants with recurrent ovarian cancer who have been previously treated with surgery alone for their early stage disease are eligible.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1 or 2
- Life expectancy greater than or equal to (\>=3) months
Exclusion
- Participants with non-epithelial ovarian cancer, ovarian tumors with low malignant potential (i.e., borderline tumors), or synchronous primary endometrial carcinoma
- Previous systemic therapy for ovarian cancer. Prior neo-adjuvant chemotherapy is allowed
- Planned intraperitoneal cytotoxic chemotherapy
- Radiotherapy within 28 days of Day 1, Cycle 1
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to first dose of Avastin
- History or evidence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>=1 arterial thromboembolic event or Grade \>=3 venous thromboembolic event within 6 months prior to enrollment
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
1021 Patients enrolled
Trial Details
Trial ID
NCT01239732
Start Date
December 1 2010
End Date
March 1 2015
Last Update
June 10 2016
Active Locations (242)
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1
Buenos Aires, Argentina, C1199ACI
2
Buenos Aires, Argentina, C1280AEB
3
Buenos Aires, Argentina, C1426ANZ
4
Rosario, Argentina, S2002KDS