S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
|ClinicalTrials.gov Identifier: NCT00014144|
Recruitment Status : Completed
First Posted : October 15, 2003
Last Update Posted : October 8, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: gefitinib||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II|
|Study Start Date :||February 2001|
|Primary Completion Date :||May 2003|
|Study Completion Date :||December 2007|
|Experimental: ZD 1839||Drug: gefitinib|
- Progression-free survival rate [ Time Frame: From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years ]
- Overall survival [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ]
- Changes in growth factor protein kinase expression [ Time Frame: Pre-treatment, post-treatment, at time of progression ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014144
Show 95 Study Locations
|Study Chair:||Daniel P. Petrylak, MD||Herbert Irving Comprehensive Cancer Center|