NCT00511992

Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Advanced Ovarian Carcinoma
• Primary Peritoneal Carcinoma
• Ovarian Carcinosarcoma

Interventions

Type	Name	Description
DRUG	Avastin	Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles
DRUG	Paclitaxel	Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
DRUG	Cisplatin	75mg/m2 IP day 2 every 21 days x 6 cycles

Timeline

• Start date: 2007-07-01
• Primary completion: 2015-08-03
• Completion: 2015-08-03
• First posted: 2007-08-06
• Last updated: 2017-07-02
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States