NCT00014144

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

Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Urethral Cancer

Interventions

Type	Name	Description
DRUG	gefitinib

Timeline

• Start date: 2001-02-01
• Primary completion: 2003-05-01
• Completion: 2007-12-01
• First posted: 2003-10-15
• Last updated: 2012-10-08

Locations

95 sites across 1 country: United States