Name of the Trial
Phase II Study of Cisplatin and Flavopiridol in Patients with Advanced Ovarian Epithelial or Primary Peritoneal Cancer (MAYO-MC0261). See the protocol summary at http://cancer.gov/clinicaltrials/MAYO-MC0261.

Dr. Keith Bible, Mayo Clinic Cancer Center

Principal Investigator
Dr. Keith Bible, Mayo Clinic Cancer Center

Why This Trial Is Important
Ovarian epithelial cancer is one of the most common gynecologic cancers in the United States. Because it is difficult to detect early, most cases of ovarian epithelial cancer are not identified until the disease has reached an advanced stage, and the long-term prognosis for patients with such disease is poor. Primary peritoneal cancer is a related but less common type of cancer that usually responds similarly to treatment.

Systemic chemotherapy with a platinum-containing drug, such as cisplatin ¹ or carboplatin ², is a commonly used treatment for advanced ovarian epithelial cancer. Although this type of treatment frequently results in tumor shrinkage, most patients ultimately become resistant to platinum-based chemotherapy.

In this trial, women with ovarian epithelial or primary peritoneal cancer whose disease has relapsed less than 6 months after treatment with initial chemotherapy will receive cisplatin and a drug called flavopiridol. Flavopiridol blocks the activity of a number of proteins that help cancer cells grow and spread, and it may also make cancer cells more sensitive to cisplatin.

"Women with platinum-resistant ovarian cancer have very few effective treatment options," said Dr. Bible. "Our laboratory studies have shown that flavopiridol can increase the platinum concentrations in cells when administered with cisplatin, and we believe that this may lead to a reversal of platinum resistance."

Who Can Join This Trial
Researchers will recruit 79 women aged 18 or over with advanced ovarian epithelial or primary peritoneal cancer treated with one prior chemotherapy regimen. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/MAYO-MC0261.

Study Site and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study sites at http://www.cancer.gov/clinicaltrials/MAYO-MC0261 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.