Atrasentan in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046943
• Other study ID #: CDR0000257127
• Secondary ID: ABBOTT-M00-258UC
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2002
• Last updated: February 18, 2011
• Start date: September 2002

Study information

• Verified date: September 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• atrasentan hydrochloride

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States,