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

SWOG Cancer Research Network

Status and phase

Completed

Phase 2

Conditions

Transitional Cell Cancer of the Renal Pelvis and Ureter

Bladder Cancer

Urethral Cancer

Treatments

Drug: gefitinib

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00014144

CDR0000068509

S0031 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

31 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)