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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Therapeutics Research Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fenretinide; Hormones

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