Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Recurrent Renal Cell Cancer
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed renal cell carcinoma Locally advanced or metastatic disease All histologic subtypes allowed Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No known brain metastases or leptomeningeal disease Performance status - ECOG 0-2 WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 No bleeding diathesis Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal (ULN) Creatinine ≤ 1.5 times ULN Creatinine clearance ≥ 60 mL/min No uncontrolled hypertension No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of sensitivity to E. coli-derived products No history of severe depression No active infection requiring antibiotics No seizure disorder requiring antiepileptic medication No medical condition likely to require systemic corticosteroids No autoimmune disorder that could result in life-threatening complications No other uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No more than 1 prior biologic response modifier regimen At least 4 weeks since prior biologic response modifiers No prior interferon alfa No prior chemotherapy At least 4 weeks since prior radiotherapy to non-index lesions Prior radiotherapy to index lesion allowed provided irradiated lesion progressed ≥ 20% in diameter At least 2 weeks since prior major surgery No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent therapeutic anticoagulation therapy Concurrent prophylactic anticoagulation, such as low-dose warfarin, for venous or arterial access device allowed provided PT, PTT, and INR are normal No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (sorafenib tosylate and recombinant interferon alfa)
Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity