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

Study Overview
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Brief Summary
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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

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

Conditions
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Carcinoma, Renal Cell

Intervention / Treatment
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* Drug: capecitabine, interferon-alpha


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All patients will receive capecitabine and interferon-alpha. | Drug: capecitabine, interferon-alpha<br>* Patients who meet inclusion/exclusion criteria will receive combination of study drugs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney cancer, capecitabine, interferon