Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
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.
Advanced Ovarian Carcinoma
Primary Peritoneal Carcinoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: Yes ]
- Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Avastin 15mg/kg IV every 21 days x 12 cycles
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511992
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||D. Scott McMeekin, MD||University of Oklahoma|