Overview

This trial is active, not recruiting.

Conditions advanced ovarian carcinoma, primary peritoneal carcinoma, ovarian carcinosarcoma
Treatment avastin
Phase phase 2
Target VEGF
Sponsor University of Oklahoma
Collaborator Genentech, Inc.
Start date July 2007
End date May 2016
Trial size 22 participants
Trial identifier NCT00511992, 2674

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
avastin Avastin
Initial Treatment: 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) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin.
time frame: 2 years

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Oklahoma.