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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2008

Interventions

  • Drug: capecitabine, interferon-alpha
    • Patients who meet inclusion/exclusion criteria will receive combination of study drugs.

Arms, Groups and Cohorts

  • Experimental: 1
    • All patients will receive capecitabine and interferon-alpha.

Clinical Trial Outcome Measures

Primary Measures

  • Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line
    • Time Frame: one year

Secondary Measures

  • Evaluate the safety and tolerability of the capecitabine and interferon combination
    • Time Frame: one year
  • Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens
    • Time Frame: one year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kidney Cancer Research Bureau
  • Provider of Information About this Clinical Study
    • Ilya Tsimafeyeu, MD, Kidney Cancer Research Bureau
  • Overall Official(s)
    • Ilya V. Tsimafeyeu, MD, Principal Investigator, Kidney Cancer Research Bureau
    • Lev V. Demidov, MD, DSc., Study Director, N.N. Blokhin Russian Cancer Research Bureau

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