Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
This trial is active, not recruiting.
|Conditions||advanced ovarian carcinoma, primary peritoneal carcinoma, ovarian carcinosarcoma|
|Sponsor||University of Oklahoma|
|Start date||July 2007|
|End date||May 2016|
|Trial size||22 participants|
|Trial identifier||NCT00511992, 2674|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin.
time frame: 2 years
Female participants at least 18 years old.
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.
|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|
|Principal investigator||D. Scott McMeekin, MD|
|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.|
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