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

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