NCT00080899

Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer

A Phase II Trial of Fenretinide (4-HPR) in Biochemically Recurrent, Hormone Naive Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die

Detailed description

PRIMARY OBJECTIVES: I. To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with fenretinide (4-HPR). II. To assess PSA doubling time as a measure of disease activity, time to PSA progression in prostate cancer patients receiving fenretinide. III. To evaluate the qualitative and quantitative toxicities of this agent in this patient population. IV. To evaluate pharmacokinetic studies on the bioavailability of 4-HPR in this patient population. OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), stage at diagnosis (organ confined vs extra-capsular extension vs lymph node positive), Gleason score at diagnosis (2-4 vs 5-6 vs 7-10), and prostate-specific antigen level at diagnosis (0-4 ng/mL vs 4.1-10 ng/mL vs \> 10 ng/mL). Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer

Interventions

Type	Name	Description
DRUG	fenretinide	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-06-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2004-04-08
• Last updated: 2015-03-06
• Results posted: 2015-03-06

Locations

1 site across 1 country: United States