Spots Global Cancer Trial Database for ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer

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Trial Identification

Brief Title: ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer

Official Title: A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent

Study ID: NCT00014183

Conditions

Kidney Cancer

Interventions

gefitinib

Study Description

Brief Summary: RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.

Detailed Description: OBJECTIVES: * Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839. * Determine the median time to objective progression in these patients receiving this drug. * Determine the toxic effects of this drug in this patient population. * Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients. OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23 months.