NCT00014144
S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
PHASE2
COMPLETED
NCT00014144
INTERVENTIONAL
Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
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.
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)
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
- TREATMENT
-
- Type: DRUG
- Name: gefitinib
- Description:
- Arm Group Labels: ZD 1839
- SWOG Cancer Research Network