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:||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|
- PFS [ Time Frame: Median PFS in months - up to 5 years ] [ Designated as safety issue: No ]Progression Free Survival: To examine the toxicity, estimate the objective response rate, and progression free survival measured in months of carboplatin, paclitaxel, and bevacizumab followed by single agent bevacizumab as consolidation for advanced mullerian cancer
- Response Rate (RECIST-1) [ Time Frame: 5 years ] [ Designated as safety issue: No ]To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.
- Toxicity [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]Per CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study
|Study Start Date:||June 2005|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Phase II
Paclitaxel carboplatin bevacizumab
Other Name: TaxolDrug: Carboplatin
Other Name: CBDCADrug: Bevacizumab
Other Name: Avastin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00129727
|Principal Investigator:||Richard T Penson, MRCP MD||MGH|