Number: GOG 9920 Principal Investigator: Mutch, David
Title: A Phase I Study of IV Doxorubicin Plus Intraperitoneal (IP) Paclitaxel and IV or IP Cisplatin in Endometrial Cancer Patients at High Risk for Peritoneal Failure
Phase: I Disease Site: Corpus Uteri
Participating Site(s):
Main Campus
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The purpose of this study is to test the safety of a chemotherapy treatment that includes both intravenous (IV – given by vein) and intraperitoneal (IP- given directly into the abdomen) administration of drugs for patients with high-risk endometrial cancer. Currently, intraperitoneal chemotherapy is commonly used as to treat patients with ovarian, fallopian tube and primary peritoneal cancer, as it targets cancer cells located in the abdominal/peritoneal cavity. There are patients with endometrial cancer who physicians would consider at high risk for the development of disease in the abdominal/peritoneal cavity and for who intraperitoneal chemotherapy might be beneficial. One of the aims of this study is to determine if giving chemotherapy directly into the abdominal/peritoneal cavity can be done safely in patients with endometrial cancer, similar to the treatment of patients with other gynecologic cancers. Intraperitoneal chemotherapy is not the current “gold standard” or preferred method of treatment for your disease. This is a Phase I study which means that while all participants treated on this study will receive the same drugs, different groups of participants will receive different doses of each drug for part of their treatment (cycles 3-6). Specifically, we will study the safety of giving the drug paclitaxel directly into the abdomen (IP) at different dose levels, and determine the best dose to use in combination with the drugs doxorubicin and cisplatin given IV (by vein). After finding the best dose of IP paclitaxel with IV doxorubicin and cisplatin, the next group of participants will then receive both IP cisplatin and IP paclitaxel to determine the safety and best doses of these drugs when given with IV doxorubicin.
More Information:
Internal Protocol Documents (requires Siteman administrative database password)