Atrasentan in Treating Patients With 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 III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.

Detailed Description
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OBJECTIVES: Determine the safety of atrasentan in patients with hormone-refractory prostate cancer. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral atrasentan once daily for 3 years in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months for 2 years. PROJECTED ACCRUAL: Approximately 1,400 patients will be accrued for this study.

Official Title
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A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: atrasentan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of hormone-refractory prostate cancer Completed protocol ABBOTT-M00-211 or ABBOTT-M00-244 within the past 30 days Disease progression OR Active in trial when double-blind treatment period ended PATIENT CHARACTERISTICS: Age 19 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC at least 3,000/mm3 Absolute neutrophil count greater than 1,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic Bilirubin less than 1.5 mg/dL AST and ALT no greater than 1.5 times upper limit of normal Renal Creatinine clearance at least 40 mL/min Cardiovascular No New York Heart Association class II-IV heart disease Pulmonary No significant pulmonary disease requiring chronic or pulse steroid therapy within the past 3 months Other Fertile patients must use 2 effective methods of contraception (1 must be barrier contraception) during and for 8 weeks after study No reason that would preclude study No significant comorbid condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 4 weeks since other prior cytotoxic chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radionuclides No concurrent radionuclides Surgery Not specified Other At least 4 weeks since prior investigational agents No concurrent antiretroviral therapy for HIV-positive patients No concurrent participation in another investigational study

Ages Eligible for Study
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Minimum Age: 19 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: atrasentan hydrochloride|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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adenocarcinoma of the prostate, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer