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    NEW SEARCH RETURN TO SEARCH RESULTS
Number: GOG 213 Principal Investigator: Mutch, David
Title: A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab Followed By Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer
Phase: III Disease Site: Multiple Sites
Participating Site(s):
 
Main Campus
Map and Directions
 
Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
Standard treatment for your type of cancer usually consists of two chemotherapy drugs, carboplatin and paclitaxel, which are given every three weeks for a total of six treatments. Chemotherapy is given to control the growth of your cancer and to lower the chance of it coming back. Treatment with chemotherapy has been found to be effective, but long term cure is uncommon. Many patients will eventually develop recurrent cancer and need additional treatment.

A newer drug, called vevacizumab, has recently been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy in patients with colon cancer that has spread to distant sites in the body. The bevacizumab being provided in this study is for investigational use only (not approved by the FDA) and is not the commercially marketed product. The commercially available bevacizumab is marketed under the name Avastin. Bevacizumab is thought to work by blocking the effect of Vascular Endothelial Growth Factor (VEGF) a protein made by tumors which can stimulate growth of tumor cells as well as blood vessels in and around tumors in some patients. Bevacizumab has been given alone on a clinical trial for patients with ovarian and primary peritoneal cancer whose tumors have recurred (come back). Approximately 18% of the 62 patients’ tumors have shrunk, and 39% have not grown in at least six months.

One purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel alone. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life (wellness and physical functioning).

A second purpose of this study is to determine if a second surgery called cytoreduction to remove tumor followed by chemotherapy can increase the time that you remain disease free. If your doctors feel that you are a good candidate for the second surgery you will be randomized to have surgery or not and at the same time you will be randomized to receive one of the two possible chemotherapy combinations. If your physician feels you are a good surgical candidate, he/she will discuss the surgical procedure with you in detail. He/she will discuss with you why or why not you would be considered for surgery. Some of the things that are taken into consideration include other medical conditions you may have, and the size and location of your tumor.

Another purpose of this study is to test samples of your blood, some of your tumor if left over from a previous surgery, and some of your tumor and normal tissue if left over from surgery performed as part of this study. The purpose of this research is to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.
 
More Information:
Internal Protocol Documents (requires Siteman administrative database password)