Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Brief summary
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
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.
Interventions
Sponsors
Abbott
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed