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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

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)