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Number: GOG 9923 Principal Investigator: Mutch, David
Title: A Phase I Study of Carboplatin/Paclitaxel/CTEP-Supplied Agent Bevacizumab and CTEP-Supplied Agent ABT-888 in Newly Diagnosed Patients with Previously Untreated Eipthelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Phase: I Disease Site: Multiple Sites
Participating Site(s):
 
 
Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
One of the purposes of this study is to test the safety of ABT-888 at different dose levels. It will be given with standard initial chemotherapy as well as a drug called bevacizumab. Standard chemotherapy for your type of cancer usually consists of two drugs called carboplatin and paclitaxel. Another purpose of this study is to test the safety of ABT-888 when given with two different dose schedules of paclitaxel. We want to find out what effects it has on you and your cancer.

Bevacizumab has been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy for patients with colon cancer, lung cancer , some types of breast cancer that have spread to distant sites in the body; and for patients with glioblastoma whose disease progressed following prior therapy; however, it is considered experimental in this study. Bevacizumab is the common name for the commercial drug Avastin. Bevacizumab is thought to work by blocking the effect of Vascular Endothelial Growth Factor (VEGF). VEGF is a protein made by tumors. It can stimulate growth of tumor cells and blood vessels around tumors in some patients.

ABT-888 is an experimental drug known as a PARP Inhibitor that kills cancer cells by preventing the repair of DNA or genetic damage. In some studies it has shown to work well with carboplatin in killing cancer cells. It can also work well in cancer cells that lack BRCA function. BRCA is a protein that helps to repair DNA damage. About 10% of ovarian cancer patients have an inherited defect in BRCA. This study combines ABT-888 with carboplatin, paclitaxel and bevacizumab.

In addition to the treatment part of this study, the researchers plan to test samples of your blood. The purpose of this research is to evaluate the effects of ABT-888 on DNA repair. Blood samples will also test for BRCA. We want to see if patients who lack BRCA respond differently to the treatment.

Additional blood tests will be taken to look at the levels of the PARP Inhibitors in your blood during the first 2 cycles of therapy.
 
More Information:
Internal Protocol Documents (requires Siteman administrative database password)