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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
Eligibility 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
Sites / Locations
- Sydney Cancer Centre at Royal Prince Alfred Hospital
- Sir Charles Gairdner Hospital - Perth
- Prince of Wales Hospital
- Cancer Institute at National University Hospital
- National Cancer Centre - Singapore
- Johns Hopkins Singapore International Medical Centre