Phase II Trial of Fenretinide (NSC 374551) in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma
I. To evaluate the efficacy of fenretinide (4-HPR) in patients with recurrent ovarian cancer
or primary peritoneal carcinoma.
II. To assess the toxicity of this agent in this patient population. III. To evaluate
molecular changes in normal and tumor cells induced by 4-HPR by studying: (a) the analysis
of ceramide and glucosyleceramide levels before and after therapy, (b) intracellular levels
of 4-HPR and 4-MPR, and (c) determinants of apoptosis (p53, p21, bcl-2, bax and terminal
deoxynucleotidyl transferase [TdT] assay) in baseline tumor specimens, serial serum and
tumor biopsy specimens where available, and surrogate in-vitro studies.
IV. To evaluate the pharmacokinetics of fenretinide. V. To further investigate the
antiangiogenesis effects of fenretinide in in-vitro assays using ovarian cancer cell lines
and in vascular growth factor (VEGF, TGFb) plasma levels in patients.
Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (CR or PR)
Associated exact 95% confidence intervals will be calculated.
Up to 9 years
University of Southern California
United States: Food and Drug Administration
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