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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kidney Cancer Research Bureau
• Treatments: Capecitabine; Interferon-alpha; Interferons; Interleukin-2

Criteria

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