Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
Study Design: This ia a Phase II study.
Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary peritoneal and papillary serous mullerian tumors will be recruited.
Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle, immediately post-operatively. This will be followed by one year of bevacizumab q21.
Outcomes: Outcomes include toxicity, response rate, and progression free survival.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Carboplatin, Paclitaxel and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer|
- To examine the toxicity, estimate the objective response rate, and progression free survival of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer [ Time Frame: TBD ] [ Designated as safety issue: Yes ]
- To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab [ Time Frame: TBD ] [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|