Phase II trial of fenretinide (4-HPR) in recurrent ovarian and primary peritoneal carcinoma: A California Cancer Consortium trial. A. A. Garcia, R. Morgan, M. McNamara, S. Scudder, D. Tsao-Wei, S. Groshen, T. Frgala, Y. Kim, C. P. Reynolds; University of Southern California, Los Angeles, CA; City of Hope, Duarte, CA; University of California-Davis, Davis, CA Abstract: Background: 4-HPR is a synthetic retinoid that, in contrast to other retinoids is cytotoxic rather than a differentiation inducer. Induction of tumor cell ceramide and reactive oxygen species have both been implicated in 4-HPR cytotoxicity. 4-HPR inhibited the growth of ovarian cancer cell lines in vitro with 1-10 ìmolar concentrations in a dose dependent manner. A recent phase I study achieved higher levels using an intermittent dosing schedule. Methods: We designed a phase II study to evaluate the activity, toxicity profile and pharmacokinetics of 4-HPR in recurrent ovarian cancer. 4-HPR was administered at a dose of 900 mg/m2 po bid for 7 days every 21 days. Patients were required to have bi-dimensionally measurable disease and could have received < 3 prior chemotherapy regimens for recurrent disease. Results: 24 patients have been enrolled; 22 are evaluable for response. Median number of prior chemotherapy regimens is 3 (range: 1-3). Only 5 patients developed grade 3 or 4 toxicity: 1 grade 3 anemia, 1 grade 4 fatigue, 1 grade 3 diarrhea, 1 grade 3 nausea, and 1 with grade 3 vomiting, diarrhea and abdominal pain. There were no treatment related deaths. The median number of cycles was 2 (range 1-35). The median number of 4-HPR cycles was 2 (range 1-35). Pharmacokinetics obtained in 18 patients showed a day 7 mean Cmax of 7.8 + 4.7 ìM (range 0.61 to 14.6 ìM). There have been no objective responses; 8 patients (33%) achieved stable disease. The median progression-free survival (PFS) was 1.5 months (95% CI 1.2-4.1) and the median survival was 9.2 months (CI 4.7-13.4). Six patients remained free of progression for more than 6 months (range 6-25); PFS at 6 months is 30% +/- 10%. Conclusions: The encouraging PFS at 6 months suggest 4-HPR may provide clinical benefit to a significant number of patients. 4-HPR was well tolerated and achieved expected plasma levels for the currently employed formulation. Abstract No: 5056 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.