S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Estimated Enrollment:	30
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

National Cancer Institute (NCI)

Investigators

Study Chair:

Daniel P. Petrylak, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Laurence H. Baker, D.O., Chairman, SWOG
ClinicalTrials.gov Identifier:	NCT00014144 History of Changes
Other Study ID Numbers:	CDR0000068509, SWOG-S0031
Study First Received:	April 10, 2001
Last Updated:	July 21, 2011
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma

Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012