S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
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|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|
|Actual Primary Completion Date :||May 2003|
|Actual Study Completion Date :||December 2007|
|Experimental: ZD 1839||
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|