Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens

Phase II Study of Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens

The aim of this study is to determine preliminary efficacy of capecitabine and interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC

Inclusion Criteria:

• Histologically or cytologically confirmed renal carcinoma
• CT-confirmed metastatic sites
• Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
• Disease progression after IL-2
• Age 18 or older
• ECOG performance status 1-3
• Life expectancy ≥ 2 months
• WBC ≥ 3,000/mm3
• Platelet count ≥ 100,000/mm3
• Hemoglobin ≥ 7.5 g/dL
• Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients)
• Total bilirubin ≤ 1.5 mg/dL
• AST ≤ 3.0 times normal
• Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases)
• Not pregnant or nursing
• No history of autoimmune
• No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV)
• No CNS metastases by neurologic exam and/or MRI
• No history of seizure disorders
• No local and/or systemic infections requiring antibiotics within 28 days prior to study entry
• No other malignancy
• Written informed consent