Carcinoma, Renal Cell
Conditions
Keywords
kidney cancer, capecitabine, interferon
Brief summary
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
Interventions
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line | one year |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety and tolerability of the capecitabine and interferon combination | one year |
| Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens | one year |
Countries
Russia