Atrasentan in Treating Patients With Prostate Cancer

NCT00046943 | Completed Phase 3

• 4 other identifiers: CDR0000257127ABBOTT-M00-258UCLA-0202002NCI-G02-2110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Interventions

atrasentan hydrochloride DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1738, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gary Gordon, MD, PhD

  Abbott

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: June 1, 2007
• Last Updated: February 21, 2011

Record last verified: 2003-09

Locations

US (1)