Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: PEG-interferon alfa-2b; gefitinib
Intervention description: PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeks; ZD1839 will be administered at a dose of 250 mg orally once daily,
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent renal cell cancer; stage IV renal cell cancer; stage III renal cell cancer

Summary:

      RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor
      and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may
      interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving
      gefitinib together with PEG-interferon alfa-2b may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gefitinib together with
      PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney
      cancer.
    

Eligibility 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