Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00046943


Primary Contact:

Gary Gordon, MD, PhD
Abbott


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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