Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma

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