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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014