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

Inclusion Criteria

• •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