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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00591188
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : May 1, 2009
Information provided by:
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

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: capecitabine, interferon-alpha Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
Study Start Date : December 2006
Actual Primary Completion Date : May 2008

Arm Intervention/treatment
Experimental: 1
All patients will receive capecitabine and interferon-alpha.
Drug: capecitabine, interferon-alpha
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluate the safety and tolerability of the capecitabine and interferon combination [ Time Frame: one year ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00591188

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Russian Federation
N.N. Blokhin Russian Cancer Research Center
Moscow, Russian Federation, 115478
Sponsors and Collaborators
Kidney Cancer Research Bureau
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Principal Investigator: Ilya V. Tsimafeyeu, MD Kidney Cancer Research Bureau
Study Director: Lev V. Demidov, MD, DSc. N.N. Blokhin Russian Cancer Research Bureau

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Responsible Party: Ilya Tsimafeyeu, MD, Kidney Cancer Research Bureau Identifier: NCT00591188    
Other Study ID Numbers: CRT-003
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009
Keywords provided by Kidney Cancer Research Bureau:
kidney cancer, capecitabine, interferon
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents