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Phase II Trial of Fenretinide (NSC 374551) in Recurrent Ovarian Cancer and Primary Peritoneal Carcinoma

Phase 2
Not Enrolling
Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Primary Peritoneal Cavity Cancer

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Trial Information

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.

Inclusion Criteria:

- Patients with histologically confirmed recurrent or metastatic epithelial ovarian
cancer or primary peritoneal carcinoma

- Unidimensionally measurable disease; indicator lesions must not have been irradiated
unless they have grown following radiation therapy

- SWOG performance status 0-2

- Patients must have received a platinum and paclitaxel containing regimen

- Patients are allowed to receive =< 2 prior chemotherapy regimens for recurrent
disease; patients who are rechallenged with the same chemotherapy regimen are
considered to have had that regimen only once

- Projected life expectancy must be at least 3 months

- Signed informed consent

- Absolute neutrophil count >= 1500/ul

- Platelet count >= 100,000 ul

- Bilirubin =< 2 times the institutional limit of normal

- ALT or AST =< 3 times the upper limit of normal

- Measured or calculated creatinine clearance >= 60 ml/min

- Fasting triglycerides =< 1 time the upper limit of normal; triglycerides may be
"normalized" prior to study entry with use of an antilipemic agent (atorvastatin,

- Patients must have recovered from acute toxicities from surgery, radiation or
chemotherapy; at least 3 weeks will have elapsed since any prior therapy directed at
the malignant tumor

- Patients of childbearing potential must agree to use an approved method of birth

Exclusion Criteria:

- Prior fenretinide is not allowed; prior 13-cis, 9-cis or all-transretinoic acid are

- Patients with a second malignancy within the last 5 years are not allowed, except for
those with non-melanomatous skin cancer and carcinoma-in-situ of the cervix; all
prior invasive malignancies must be in complete remission

- The use of concomitant antioxidants, such as vitamin C or E, is not allowed

- Patients with concurrent medical, psychological or social conditions of such severity
that the investigator deems it unwise to enter the patient on protocol

- Untreated or symptomatic brain metastases

- Pregnant or nursing women

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (CR or PR)

Outcome Description:

Associated exact 95% confidence intervals will be calculated.

Outcome Time Frame:

Up to 9 years

Safety Issue:


Principal Investigator

Agustin Garcia

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

Related Keywords:

  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Primary Peritoneal Cavity Cancer
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



University of Southern California Los Angeles, California  90033