Pilot Study of Taxol, Carboplatin, and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
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.