NCT00014144

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

Official Title:

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

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.

Eligibility

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)

Disease(s) and\or Condition(s)

Bladder Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Urethral Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: gefitinib
    • Description:
    • Arm Group Labels: ZD 1839
Sponsor
  • SWOG Cancer Research Network