NCT00017134

Fenretinide Followed by Surgery Compared With Surgery Alone in Preventing Ovarian Cancer in Patients at Increased Risk

An Exploratory Evaluation of Fenretinide (4-HPR) as a Chemopreventive Agent for Ovarian Carcinoma

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	fenretinide
PROCEDURE	conventional surgery

Timeline

• Start date: 2002-09-01
• Primary completion: 2006-12-01
• First posted: 2003-05-07
• Last updated: 2013-06-10

Locations

35 sites across 1 country: United States