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Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Ovarian Carcinoma; Primary Peritoneal Carcinoma; Ovarian Carcinosarcoma

Intervention: Avastin (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: University of Oklahoma

Official(s) and/or principal investigator(s):
D. Scott McMeekin, MD, Principal Investigator, Affiliation: University of Oklahoma

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
Additional Information

Starting date: July 2007
Last updated: May 29, 2015

Page last updated: August 20, 2015

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