Atrasentan in Treating Patients With Prostate Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Atrasentan

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