(MC1114) A Phase I Trial of the Combination of the PARP Inhibitor ABT-888 with Intraperitoneal Floxuridine (FUDR) in Epithelial Ovarian, Primary Peritoneal and Fallopian tube Cancers
This study is being done to find out more about the side effects of ABT-888 and floxuridine when given together and what doses of ABT-888 and floxuridine are safe for people. Everyone in this study will receive ABT-888 and floxuridine.Specifically, this study is being done to: 1)determine the maximum tolerated dose of the combination of ABT-888 and IP floxuridine in adult patients with advanced ovarian, primary peritoneal or fallopian tube cancer; 2)assess for preliminary evidence of efficacy, such as tumor responses, of the treatment combination; and 3)assess PSF (Progression Free Survival) in the MTD cohort.
- Disease confined to the intraperitoneal and retroperitoneal cavity.- Candidate for and willingness to have a surgically placed intraperitoneal catheter and tissue acquisition at the time of port placement. NOTE: If an intraperitoneal catheter is already in place, a tumor biopsy will still be required. A guided core-needle biopsy is sufficient in these cases.- Maximum of 4 prior chemotherapy regimens- Good lab values and performance status
All treatment will be given outpatient. ABT-888 orally twice per day on days 1-10. Floxuridine IP (intraperitoneally) to gravity (approx 3 hrs) once per day on days 3-5. Cycles are repeated every 3 weeks. Cycles will continue until disease progression or unacceptable side effects.
12/09/2013 04:02 AM