search
Back to results

Atrasentan in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
atrasentan hydrochloride
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept 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 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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2002
Last Updated
February 18, 2011
Sponsor
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT00046943
Brief Title
Atrasentan in Treating Patients With Prostate Cancer
Official Title
A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2003
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
atrasentan hydrochloride

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Gordon, MD, PhD
Organizational Affiliation
Abbott
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1738
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Atrasentan in Treating Patients With Prostate Cancer

We'll reach out to this number within 24 hrs