Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed renal cell carcinoma

  • Metastatic or advanced/unresectable disease
• Measurable or nonmeasurable disease as defined by RECIST criteria

• No uncontrolled brain metastases

  • Patients with adequately treated brain metastases who are not taking anticonvulsants and corticosteroids may be eligible

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy ≥ 12 weeks
• WBC ≥ 3,500/mm³
• Platelet count ≥ 100,000/mm³
• Absolute granulocyte count ≥ 1,500/mm³
• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
• Bilirubin ≤ 1.5 mg/dL
• AST ≤ 2 times upper limit of normal (ULN)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission
• No known severe hypersensitivity to gefitinib or its excipients
• No incomplete healing from previous oncologic or other major surgery
• No unresolved chronic toxicity > grade 2 from previous anticancer therapy (except alopecia and anemia)

• No evidence of clinically active interstitial lung disease

  • Patients with chronic stable radiographic changes who are asymptomatic are eligible
• No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• No other significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

• More than 30 days since prior nonapproved or investigational drugs
• More than 6 weeks since prior aldesleukin or interferon and recovered
• At least 3 weeks since prior radiotherapy
• No prior gefitinib
• Prior chemotherapy or biological therapy allowed
• Prior or concurrent bisphosphonate therapy for bone metastases allowed
• No concurrent phenytoin, carbamazepine, rifampin, barbiturates, phenobarbital, or Hypericum perforatum (St. John's wort)
• No other concurrent agents specifically designed to inhibit the epidermal growth factor receptor (EGFR)
• No concurrent radiotherapy to measurable lesions