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

Overview

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 Title of Study: “Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2003

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.

Interventions

  • Drug: gefitinib

Arms, Groups and Cohorts

  • Experimental: ZD 1839

Clinical Trial Outcome Measures

Primary Measures

  • Progression-free survival rate
    • Time Frame: From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years

Secondary Measures

  • Overall survival
    • Time Frame: From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years
  • Confirmed complete and partial response to ZD 1839
    • Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years
  • Number and grade of adverse events to ZD 1839
    • Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • SWOG Cancer Research Network
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel P. Petrylak, MD, Study Chair, Herbert Irving Comprehensive Cancer Center

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