RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep
growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells
PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have
metastatic kidney cancer.
OBJECTIVES: I. Determine the efficacy of ZD 1839 in patients with metastatic renal cell
cancer. II. Determine the time to disease progression in patients treated with this drug.
III. Determine the safety of this drug in these patients.
OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Patients are followed for at least
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 1 year.
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma
Bidimensionally measurable disease Bone metastasis as only site must have at least 1
bidimensionally measurable tissue mass by CT or MRI (e.g., expansile lesion) Radiologic
evidence of disease progression or symptoms related to disease No brain metastases
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than
1.5 mg/dL ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine
no greater than 1.5 times ULN Other: No prior malignancy within the past 5 years unless
potentially curatively treated or deemed at low risk for recurrence Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered No more than 1 prior biologic regimen No other concurrent biologic therapy
Chemotherapy: At least 4 weeks since prior cytotoxic therapy and recovered No more than 1
prior cytotoxic regimen No concurrent cytotoxic therapy Endocrine therapy: At least 4
weeks since prior hormonal therapy and recovered No more than 1 prior hormonal regimen No
concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No
concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery