Gynecologic Cancer Study
GOG 0218: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paciltaxel Plus Concurrent Bevacizumab Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed , Previously Untreated, Stage III or IV, Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Protocol ID
Protocol Description
Standard chemotherapy for ovarian, peritoneal primary or fallopian tube cancer usually consists of two drugs called carboplatin and paclitaxel, which are given every three weeks for a total of six treatments. Chemotherapy is given to control the growth of cancer and to lower the chance of it coming back. This treatment 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 bevacizumab, has been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy in patients with colon cancer, lung cancer and some types of breast cancer that have spread to distant sites in the body. 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) a protein made by tumors which can stimulate growth of tumor cells as well as blood vessels in and around tumors in some patients.
The purpose of this study is to compare the combination of carboplatin, paclitaxel and bevacizumab to the standard combination of carboplatin and paclitaxel aloneovarian, peritoneal primary or fallopian tube cancer. Effectiveness of treatment will be measured in terms of survival, time without evidence of cancer growth and quality of life (wellness and physical functioning).In addition to the treatment part of this study, the researchers plan to test samples of your tumor, (if available from a previous surgery or biopsy), and your blood. The purpose of this research is to determine if this testing can be used in the future to determine ahead of time which patients may respond to treatment or have good prognosis.
Eligibility Criteria
Women with Newly Diagnosed , Previously Untreated, Stage III or IV, Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Primary Investigator(s)
- Veena John, MD