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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.

Principal Investigator

Dr. Keith Bible 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 or carboplatin, 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 second 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.

"An early analysis of patients currently on the trial has revealed a better than expected response rate, including one patient with a complete remission," he added.

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.

Study Site and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study sites 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.

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