Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
- Conditions
- Advanced Ovarian CarcinomaPrimary Peritoneal CarcinomaOvarian Carcinosarcoma
- Interventions
- Registration Number
- NCT00511992
- Lead Sponsor
- University of Oklahoma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Avastin Avastin - Avastin Cisplatin - Avastin Paclitaxel -
- Primary Outcome Measures
Name Time Method Number of Patients Able to Complete 6 Cycles of Treatment. 2 years Completion of cycle 6
- Secondary Outcome Measures
Name Time Method Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. 2 years CTCAE assessment of toxicity
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States