Pilot Study of Taxol, Carboplatin, and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow & Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like bevacizumab have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients and are being studied for their potential contributory impact on the current standard of treatment. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.
The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response rate (RR).
The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy.
Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Open-Label, Non-Randomized, Multi-Center Pilot Study of Intravenous Taxol, Carboplatin, Bevacizumab Given Every 21 Days in Patients With Newly Diagnosed Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer|
- time to tumor progression
- response rate
|Study Start Date:||August 2004|
|Study Completion Date:||October 2012|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Paclitaxel, Carboplatin and Avastin on day1 every 21 days
Paclitaxel, Carboplatin and Avastin given on day 1 every 21 days
Other Name: Bevacizumab
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127920
|United States, California|
|Gynecologic Oncology Associates|
|Newport Beach, California, United States, 92663|
|United States, Florida|
|Florida Hospital College of Health Sciences|
|Orlando, Florida, United States, 32803|
|Principal Investigator:||John P Micha, MD||Gynecologic Oncology Associates|