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
Overview
- Phase
- Phase 2
- Intervention
- Avastin
- Conditions
- Advanced Ovarian Carcinoma
- Sponsor
- University of Oklahoma
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of Patients Able to Complete 6 Cycles of Treatment.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
- •Adequate bone marrow, renal, and hepatic function
- •Patients must be entered no more than twelve weeks postoperatively
Exclusion Criteria
- •Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
- •Stage IV or suboptimally debulked disease following primary cytoreductive surgery
- •Patients who have received prior radiotherapy or chemotherapy.
Arms & Interventions
Avastin
Intervention: Avastin
Avastin
Intervention: Paclitaxel
Avastin
Intervention: Cisplatin
Outcomes
Primary Outcomes
Number of Patients Able to Complete 6 Cycles of Treatment.
Time Frame: 2 years
Completion of cycle 6
Secondary Outcomes
- Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.(2 years)