3-AP in Treating Patients With Advanced Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy.

Detailed Description
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OBJECTIVES: Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP. Determine the toxic effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive 3-AP IV over 2 hours on days 1-4. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for up to 1 year. PROJECTED ACCRUAL: Approximately 13-27 patients will be accrued for this study.

Official Title
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A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) in Patients With Advanced Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: triapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: triapine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage IV prostate cancer