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: Phase II trial to study the effectiveness of fenretinide in treating patients who have advanced or metastatic hormone-refractory prostate cancer.

Condition	Treatment or Intervention	Phase
recurrent prostate cancer stage III prostate cancer stage IV prostate cancer adenocarcinoma of the prostate	Drug: fenretinide  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Australia, New South Wales
      Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney,  New South Wales,  2050,  Australia; Recruiting
Australia, Western Australia
      Sir Charles Gairdner Hospital - Perth, Perth,  Western Australia,  6009,  Australia; Recruiting
Hong Kong
      Prince of Wales Hospital, Shatin, New Territories,  Hong Kong; Recruiting
Singapore
      Cancer Institute at National University Hospital, Singapore,  119074,  Singapore; Recruiting
      Johns Hopkins - Singapore, Singapore,  119074,  Singapore; Recruiting
      National Cancer Centre - Singapore, Singapore,  169610,  Singapore; Recruiting

Study chairs or principal investigators

Michael Boyer,  Study Chair,  Sydney Cancer Centre at Royal Prince Alfred Hospital   

Study ID Numbers:  CDR0000350305; CTRG-P18/02; NCI-6062; NCT00077402
Record last reviewed:  January 2005
Last Updated:  February 4, 2005
Record first received:  February 10, 2004
ClinicalTrials.gov Identifier:  NCT00077402
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08