Atrasentan in Treating Patients With Prostate Cancer

NCT ID: NCT00046943

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30

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.

Conditions

Prostate Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

atrasentan hydrochloride

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gary Gordon, MD, PhD

Role:

Abbott

Locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

ABBOTT-M00-258

Identifier Type: -

Identifier Source: secondary_id

UCLA-0202002

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2110

Identifier Type: -

Identifier Source: secondary_id

CDR0000257127

Identifier Type: -

Identifier Source: org_study_id