Atrasentan in Treating Patients With Prostate Cancer

February 18, 2011 updated by: Abbott

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1738
        • Jonsson Comprehensive Cancer Center, UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Gary Gordon, MD, PhD, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 21, 2011

Last Update Submitted That Met QC Criteria

February 18, 2011

Last Verified

September 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000257127
  • ABBOTT-M00-258
  • UCLA-0202002
  • NCI-G02-2110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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