IRB Number:

24-04

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This research study is being done to learn the effects (good and bad) of the drugs flavopiridol and cisplatin when given together to patients with ovarian and primary peritoneal cancer.

Who is Eligible to Participate in the Study?

Women over the age of 18 who have been diagnosed with ovarian or peritoneal cancer may be eligible to participate in this research study.

What is Involved With this Study?

If you agree to take part in the study, you will need to have a central venous catheter (also known as a PICC or Port-a-cath) in place before starting the study drugs. The catheter is a small plastic tube inserted in a vein and can be connected to a small pump that is worn on your belt or over your shoulder. The pump allows the drug to be given continually over 24 hours while you can move around freely. If you do not already have one, a catheter will need to be placed before you begin the study. You can have this procedure done as an outpatient. The catheter will need to stay in place during the study.

During the study, the health care team may talk about "cycles" of treatment. A cycle is a scheduled period of time for taking the cancer treatment drugs. For this study, each cycle is 21 days (or 3 weeks) long. You will need to return to your study center at least once each cycle to get the study drug and for physical exams, blood tests, and/or x-rays or scans. You will also need to have weekly blood tests to measure your blood cell counts, but these may be done in your hometown clinic or doctor's office. More frequent testing or other kinds of tests may be done if your doctors feel these are needed as part of the routine medical care for your cancer.

The study drugs, cisplatin and flavopiridol, may be given once every 3 weeks for as long as the drugs may be helpful and you do not have bad side effects.

How long will the Study run?

You will get treatment with both drugs until they are no longer helpful, or if you or your doctor think that the side effects of the treatment are too serious. You will be followed for up to three years after you have stopped getting the drugs so that the researchers can watch your health status.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 05/07/2008