Clinical Trial: Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: PHASE II STUDY OF PACLITAXEL (TAXOL), INTRAPERITONEAL CISPLATIN AND IV AVASTIN FOLLOWED BY AVASTIN CONSOLIDATION FOR ADVANCED OVARIAN AND PERITONEAL CARCINOMA OR FALLOPIAN TUBE CANCER

Brief Summary: The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Detailed Summary:

Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Sponsor: University of Oklahoma

Current Primary Outcome: Evaluating the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment. [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin. [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: University of Oklahoma

Dates:
Date Received: August 3, 2007
Date Started: July 2007
Date Completion: May 2016
Last Updated: May 29, 2015
Last Verified: May 2015