Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with advanced or metastatic hormone-refractory prostate cancer.

Detailed Description
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OBJECTIVES: Primary Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer. Secondary Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug. Determine the duration of PSA response in patients treated with this drug. Determine PSA progression-free survival of patients treated with this drug. Determine overall survival of patients treated with this drug. Determine the toxicity of this drug in these patients. Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug. OUTLINE: This is a multicenter, open-label study. Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each course, and at the end of therapy. PROJECTED ACCRUAL: Approximately 21-50 patients will be accrued for this study.

Official Title
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A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: fenretinide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the prostate Measurable or non-measurable disease Metastatic disease allowed Castrate levels of serum testosterone (either after orchiectomy or maintained on a luteinizing hormone-releasing hormone agonist or antagonist) Prostate-specific antigen (PSA) greater than 10 ng/mL at baseline and rising, with 2 consecutive increases measured at least 1 week apart* No known brain metastases NOTE: *If the third PSA value has not risen above the second PSA value, a fourth measurement must be obtained that is higher than the second value PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-1 Life expectancy More than 12 weeks Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 WBC greater than 3,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic AST and ALT no greater than 2.5 times upper limit of normal Bilirubin normal Renal Creatinine normal OR Creatinine clearance greater than 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Able to tolerate oral medication Fertile patients must use effective contraception No prior allergic reaction to compounds of similar chemical or biological composition to fenretinide No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior cytotoxic chemotherapy Endocrine therapy See Disease Characteristics At least 6 weeks since prior antiandrogen therapy with any of the following: Cyproterone Flutamide Bicalutamide Nilutamide Concurrent corticosteroids allowed provided therapy was initiated before study entry Radiotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy, including for pain No concurrent radioisotopes (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) Other More than 4 weeks since prior investigational agents No concurrent antioxidants (e.g., ascorbic acid or vitamin E), vitamin A, or beta carotene supplements No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial anticancer agents or therapies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fenretinide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as measured by RECIST at ≥ 9 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as measured by NCI CTC |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate