S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract

Phase 2

Completed

• Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
• Interventions: Drug: gefitinib

• Registration Number: NCT00014144
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of cancer of the urinary tract.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have advanced cancer of the urinary tract.

Detailed Description

OBJECTIVES:

* Determine the 6-month progression-free survival rate of patients with advanced transitional cell carcinoma of the urothelium treated with ZD 1839.

* Determine the overall survival and response (confirmed complete and partial response) in these patients treated with this regimen.

* Determine the qualitative and quantitative toxicity of this regimen in these patients.

* Evaluate the changes in growth factor protein kinase expression before and after treatment and at the time of disease progression in these patients treated with this regimen.

OUTLINE: Patients receive oral ZD 1839 once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2001-04-10
• Primary Completion: 2003-05
• Study First Submitted QC: 2003-10-14
• Study First Posted: 2003-10-15
• Study Completion: 2007-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZD 1839	gefitinib	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival rate	From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years
Confirmed complete and partial response to ZD 1839	From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
Number and grade of adverse events to ZD 1839	From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

Trial Locations

Locations (95)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

CCOP - Greater Phoenix; 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Phoenix (Hayden); 🇺🇸 Phoenix, Arizona, United States

Veterans Affairs Medical Center - Tucson; 🇺🇸 Tucson, Arizona, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Veterans Affairs Medical Center - Little Rock (McClellan); 🇺🇸 Little Rock, Arkansas, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

Veterans Affairs Medical Center - Long Beach; 🇺🇸 Long Beach, California, United States

Scroll for more (85 remaining)