Trial Information

Summary: Ovarian Cancer Study CEPO906A2303

Novartis Oncology is conducting a clinical research study to find out if the study drug patupilone is safe, prolongs survival, and has any additional beneficial effects in patients with ovarian, primary fallopian, or primary peritoneal cancer who did not respond to chemotherapy or whose disease came back after chemotherapy. Pegylated liposomal doxorubicin is chemotherapy approved by the FDA for use in ovarian, primary fallopian, or primary peritoneal cancer and is a standard treatment for this type of cancer at this stage of the disease. Because we do not know which medicine is best, we need to make a comparison of the two products: pegylated liposomal doxorubicin and patupilone. Study patients may get either 10 mg/m2 patupilone once every three weeks or 50 mg/m2 of pegylated liposomal doxorubicin once every four weeks, intravenously (directly into a vein). Study patients will have a 50% chance of being assigned to receive either the study drug patupilone or pegylated liposomal doxorubicin. Patients are assigned to a particular treatment by an automatic system. Patients or doctors will not have a choice of which medication the patient will receive. The study drug, Patupilone, is a medicine which has not been approved by the FDA (US Food and Drug Administration) or the EMEA (European Medicines Agency).

1 hour visit to study site, every 3-4 wks for treatment and evaluations. After completion of study treatment, you will be asked to come to the study site every 3 months to see how you're doing and follow the progress of your disease.
For more information about this clinical trial, visit www.NovartisClinicalTrials.com

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Trial listings updated: June 27, 2008 at 1:00:22 PM