Atrasentan in Treating Patients With Prostate Cancer

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00046943

Collaborator

(none)

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: atrasentan hydrochloride	Phase 3

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2002

Actual Primary Completion Date :

Jun 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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