Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)
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|ClinicalTrials.gov Identifier: NCT00129727|
Recruitment Status : Completed
First Posted : August 12, 2005
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of Carboplatin, Paclitaxel and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Experimental: Phase II
Paclitaxel carboplatin bevacizumab
Other Name: Taxol
Other Name: CBDCA
Other Name: Avastin
- PFS [ Time Frame: Median PFS in months - up to 5 years ]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 ]To estimate the objective response rate of carboplatin, paclitaxel, and bevacizumab. Evaluate toxicity.
- Toxicity [ Time Frame: 60 months ]Per CTCAE (Common Toxicity Criteria for Adverse Events) number of participants who experienced toxicity on the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129727
|Principal Investigator:||Richard T Penson, MRCP MD||MGH|