(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
Johns Hopkins Kimmel Cancer Center in Baltimore
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.
06/28/2016 05:03 AM