TRIAL OF PACLITAXEL AND CARBOPLATIN VERSUS COMBINATIONS IN PATIENTS WITH CANCER

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Ovarian cancer and primary peritoneal cancer strikes over 20,000 women each year in the United States. Most women present with advanced disease. Those with advanced disease will have higher rates of relapse or persistent disease. The standard drug treatment following surgery is with two platinum-based drugs (Carboplatin, paclitaxel, and more recently cisplatin). Despite recent improvement in management, a significant number of patients, approximately 25% will have a recurrence of their cancer. Thus, the challenge is to find an optimal treatment regimen agent(s) that will improve overall survival, and decrease the percentage of recurrence. There are three new drugs which have been shown to be successful in the treatment of ovarian and peritoneal cancer. These drugs are Gemcitabene, Topotecan and Doxil given alone or in combination with the standard treatments. This study will look at the effectiveness of adding one of these drugs to the standard drug regimen of Carboplatin or Paclitaxel. Studies have shown that ovarian cancer can run in families. BRCA 1 and BRCA 2 are two genes that have been found in the blood or tumors of these women. It is possible that these women may respond differently to chemotherapy treatment than women who do not have one of these genes. Therefore, a second purpose of this study is to look at whether there is a difference in survival in women who have these genes. Blood and tumor tissue will be analyzed in order to identify these patients in the study who have these genes and compare them to women who do not. This study will also look at the side effects associated with the new combinations compared to the standard treatments.