Atrasentan in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00046943
First received: October 3, 2002
Last updated: February 18, 2011
Last verified: September 2003
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: atrasentan hydrochloride
Phase 3

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046943

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1738
Sponsors and Collaborators
Abbott
Investigators
Investigator: Gary Gordon, MD, PhD Abbott
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00046943     History of Changes
Other Study ID Numbers: CDR0000257127, ABBOTT-M00-258, UCLA-0202002, NCI-G02-2110
Study First Received: October 3, 2002
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014