Completed

NCT Number: NCT00046943

Atrasentan in Treating Patients With Prostate Cancer

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.

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1738, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atrasentan hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2007
First posted: Jan 27, 2003
Registry last updated: Feb 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed