gefitinib and peg-interferon alfa-2b in treating patients with unresectable or metastatic kidney cancer

Conditions: Kidney 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.

objectives: primary * determine the 6-month progression-free survival of patients with unresectable or metastatic renal cell carcinoma treated with gefitinib and peg-interferon alfa-2b. secondary * determine the response rate (by recist criteria), duration of response, time to treatment failure, and overall survival of patients treated with this regimen. * assess toxicity and tolerability of this regimen in these patients. * determine the pre-treatment expression of the von hippel-lindau (vhl) protein, the epidermal growth factor receptor (egfr), and p27, and correlate with response to treatment. * determine post-treatment alteration of egfr and p27 expression in patients with tumors accessible for serial biopsy. * assess changes in egfr levels in buccal epithelial cells in patients treated with this regimen. outline: this is a multicenter study. patients receive oral gefitinib once daily and peg-interferon alfa-2b subcutaneously once weekly in weeks 1-6. treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. patients with a partial response or stable disease after completion of course 2 continue to receive gefitinib alone as above in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically for up to 2 years. projected accrual: a total of 39 patients will be accrued for this study.

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

Keywords: recurrent renal cell cancer stage iv renal cell cancer stage iii renal cell cancer