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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
75mg/m2 IP day 2 every 21 days x 6 cycles
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Number of Patients Able to Complete 6 Cycles of Treatment.
Completion of cycle 6
Time frame: 2 years
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
CTCAE assessment of toxicity
Time frame: 2 years
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