Ovarian Cancer Clinical Trial
Official title:
An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development of cancer. It is not yet known whether fenretinide given before surgery is more
effective in preventing ovarian cancer than surgery alone.
PURPOSE: Randomized clinical trial to compare the effectiveness of fenretinide followed by
surgery with that of surgery alone in preventing ovarian cancer in patients who are at
increased risk.
OBJECTIVES:
- Compare the frequency of histopathology markers or precursor lesions of the ovaries,
including surface papillomatosis, invaginations, pseudostratification, and inclusion
cysts, removed from patients at increased risk for ovarian cancer between those
receiving fenretinide vs those undergoing immediate oophorectomy.
- Determine the relative abundance of markers of cell proliferation and apoptosis in
cancer-prone ovaries of patients treated with fenretinide.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo prophylactic oophorectomy.
- Arm II: Patients receive oral fenretinide once daily for 27 days every 30 days for 6-8
weeks. Treatment continues in the absence of unacceptable toxicity or diagnosis of
malignancy. After completion of fenretinide, patients undergo prophylactic
oophorectomy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 years.
;
Allocation: Randomized, Primary Purpose: Prevention
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