Title:
(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
Protocol Number:
G9927
Phase:
Phase I
Physician:
Deborah Armstrong
Purpose:
- To determine the maximum tolerated doses and dose-limiting toxicities of two different regimens of ABT-888 when administered with carboplatin and PLD (Doxil®, Lipodox�) 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.
Eligibility:
- 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
Treatment:
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.
Population:
Adult
Last Update
05/21/2013 04:02 AM
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