3-AP in Treating Patients With Advanced Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of hormone-refractory metastatic prostate cancer by one of the following methods: Measurable disease PSA level of at least 5 ng/mL with a positive bone scan Objective evidence of progressive metastatic disease in the past 3 months defined by any of the following: An increase in PSA value of at least 25% (minimum absolute increase of 5 ng/mL) on at least 2 successive occasions, at least 2 weeks apart A new symptomatic lesion on bone scan A new metastases not in bone Growth of existing non-bone measurable metastatic disease NOTE: An increase in pain or symptoms alone without other evidence of progression, or elevation of PSA or serum alkaline phosphatase alone without evidence of metastatic disease is not sufficient Prior bilateral orchiectomy or other primary hormonal treatment with evidence of treatment failure Patients with no prior bilateral orchiectomy must have a testosterone level less than 50 ng/mL and must continue leuteinizing hormone-releasing hormone therapy while on study No known active CNS metastases (excluding prior CNS metastases with currently stable disease after treatment ) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 5 times upper limit of normal Albumin greater than 2.5 g/dL Chronic hepatitis allowed Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No unstable angina No uncontrolled arrhythmias No uncontrolled congestive heart failure Pulmonary No dyspnea at rest Other Nutrition adequate (caloric intake considered adequate for maintenance of weight) Fertile patients must use effective contraception No prior or concurrent malignancies except for non-metastatic basal cell or squamous cell skin cancer or any stage I malignancy curatively resected more than 5 years ago No active uncontrolled infectious process No other life-threatening illness No peripheral neuropathy greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy At least 2 weeks since prior biologic therapy Chemotherapy At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy See Disease Characteristics At least 4 weeks since other prior hormonal therapy including any of the following: Megestrol Finasteride Herbal products known to decrease PSA levels (e.g., saw palmetto and PC-SPES) Systemic corticosteroids At least 4 weeks since prior flutamide therapy (6 weeks for bicalutamide or nilutamide) with continued evidence of progressive disease documented by at least 1 PSA value after discontinuation Radiotherapy At least 8 weeks since prior radiopharmaceuticals (strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium) At least 4 weeks since prior radiotherapy and recovered Surgery See Disease Characteristics At least 3 weeks since prior major surgery and recovered Other No other concurrent investigational agents No other concurrent anticancer treatment
Sites / Locations
- UCSF Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute