A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer
Data Collection
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
Sir Charles Gairdner Hospital - Perth
Perth, AustraliaPrince of Wales Hospital
Shatin, New Territories, Hong KongCancer Institute at National University Hospital
Singapore, Singapore