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

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: capecitabine, interferon-alpha

• Registration Number: NCT00591188
• Lead Sponsor: Kidney Cancer Research Bureau

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Primary Completion: 2008-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	capecitabine, interferon-alpha	All patients will receive capecitabine and interferon-alpha.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

N.N. Blokhin Russian Cancer Research Center; 🇷🇺 Moscow, Russian Federation