(GOG 9927) A PHASE I TRIAL OF PEGYLATED LIPOSOMAL DOXORUBICIN,(PLD) CARBOPLATIN AND NCI SUPPLIED VELIPARIB (ABT-888) IN RECURRENT PLATINUM SENSITIVE OVARIAN, PRIMARY PERITONEAL AND FALLOPIAN TUBE CANCER
- To determine the maximum tolerated doses and dose-limiting toxicities of two different regimens of ABT-888 when administered with carboplatin and PLD (DoxilÂ®, Lipodoxâ?¢) in recurrent, platinum sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer. - To estimate the objective response rate (complete and partial) in patients with measureable disease.
- platinum sensitive recurrent ovarian cancer - may have an unlimited number of platinum based therapies - may only have one non-platinum therapy in recurrent setting - no prior PARP inhibitors - no prior anti-angiogenic (ie bevacizumab) in recurrent setting - may have measurable disease, detectable disease or biochemical recurrence(elevated CA-125 - good lab values, performace status and organ function
This is an outpatient regimen consisting of two regimens. Both groups will receive IV PLD and IV Carboplatin every 28 days. Both groups will receive ABT-888 orally either on Days 1-7 or Days 1-28 in alternating groups.
05/21/2013 04:02 AM