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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014144 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: gefitinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II |
| Study Start Date: | February 2001 |
OBJECTIVES:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra) not curable by surgery or radiotherapy
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 95 Study Locations| Study Chair: | Daniel P. Petrylak, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068509, SWOG-S0031 |
| Study First Received: | April 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00014144 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Urinary Tract Neoplasm Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Recurrence Carcinoma |
Renal Cancer Urologic Diseases Kidney Neoplasms Urethral Cancer Urethral Neoplasms Bladder Neoplasm Kidney Diseases Gefitinib Ureteral Neoplasms Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Urethral Neoplasms Urethral Diseases Kidney Diseases Ureteral Neoplasms Neoplasms, Glandular and Epithelial |