Ovarian Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Avastin (A) or Avastin and Erlotinib (AE) as First Line Consolidation Chemotherapy After Carboplatin, Paclitaxel, and Avastin (CTA) Induction Therapy for Newly Diagnosed Advanced Ovarian, Fallopian Tube, Primary Peritoneal Cancer & Papillary Serous or Clear Cell Mullerian Tumors
The purpose of this research study is to evaluate how patients with newly diagnosed advanced ovarian, fallopian tube, primary peritoneal cancer and papillary serous or clear cell mullerian tumors respond to consolidation therapy with Avastin and erlotinib or Avastin alone over 1 year. These drugs have been used in the treatment of other types of cancers and information from those studies suggests that these agents may help to treat the cancers studied here.
Objectives:
Primary To examine the progression free survival (PFS) of Avastin and Erlotinib (AE) or
Avastin (A) as consolidation therapy.
Secondary To examine the toxicity between the two consolidative regimens AE vs. A. To assess
the response rate of CTA.
STATISTICAL DESIGN This study uses a randomized selection design. Both consolidation
treatment arms are deemed experimental and are compared against a historical control [McGuire
WP et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients
with stage III and stage IV ovarian cancer. NEJM 1996: 334:1-6. PMID:7494563]. With 30
patients in a given arm and 6 months of follow-up, there was 80% power to detect a 61.5%
increase in median PFS from 13 months to 21 months assuming 1-sided 10% significance.
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