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ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
This study is ongoing, but not recruiting participants.
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

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: ZD1839
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014144

  Show 95 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Daniel P. Petrylak, MD Herbert Irving Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000068509, SWOG-S0031
Study First Received: April 10, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00014144  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Ureteral Diseases
Urogenital Neoplasms
Renal cancer
Kidney cancer
Carcinoma, Transitional Cell
Urologic Neoplasms
Transitional cell carcinoma
Recurrence
Carcinoma
Urethral cancer
Urologic Diseases
Kidney Neoplasms
Urethral Neoplasms
Kidney Diseases
Gefitinib
Ureteral Neoplasms
Urinary tract neoplasm
Bladder neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Urethral Diseases

ClinicalTrials.gov processed this record on January 16, 2009