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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra) not curable by surgery or radiotherapy Any T, N0-3, M1 or unresectable M0 Poorly differentiated TCC, predominant TCC with rare foci of squamous differentiation, or rare foci of adenocarcinoma allowed Measurable disease At least 1 lesion accessible for biopsy Soft tissue disease that has been irradiated within the past 2 months not considered measurable disease Progressive or recurrent disease after only 1 prior systemic chemotherapy regimen for advanced disease No adenocarcinoma, small cell carcinoma, sarcoma, squamous cell carcinoma, or mixed histology PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,200/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) Chemotherapy: See Disease Characteristics No prior adjuvant chemotherapy At least 28 days since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 28 days since prior radiotherapy and recovered Surgery: See Disease Characteristics At least 28 days since prior surgery and recovered Other: No prior systemic therapy between biopsy and study entry At least 28 days since prior intravesical therapy and recovered No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, or St. John's Wort)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZD 1839<br> | Drug: gefitinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, anterior urethral cancer, posterior urethral cancer