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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: gefitinib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV or recurrent renal cell carcinoma not amenable to potentially curative surgery Evidence of disease progression Measurable disease At least 20 mm with conventional techniques OR At least 10 mm with spiral CT scan No brain metastases Malignant tissue available PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: More than 2 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No prior allergy to compounds of similar chemical or biologic composition to ZD 1839 No ongoing or active infection No other uncontrolled illness or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens At least 4 weeks since prior immunotherapy and recovered No concurrent immunotherapy Chemotherapy: No more than 1 prior chemotherapy regimen At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: No prior therapy for metastatic disease No other concurrent investigational agents No concurrent oral retinoids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer