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

Fecha de inicio: 1 de noviembre de 2003

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