Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
NCT ID: NCT00591188
Last Updated: 2009-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
All patients will receive capecitabine and interferon-alpha.
capecitabine, interferon-alpha
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.
Interventions
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capecitabine, interferon-alpha
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Kidney Cancer Research Bureau
OTHER
Responsible Party
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Kidney Cancer Research Bureau
Principal Investigators
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Ilya V. Tsimafeyeu, MD
Role: PRINCIPAL_INVESTIGATOR
Kidney Cancer Research Bureau
Lev V. Demidov, MD, DSc.
Role: STUDY_DIRECTOR
N.N. Blokhin Russian Cancer Research Bureau
Locations
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N.N. Blokhin Russian Cancer Research Center
Moscow, , Russia
Countries
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Other Identifiers
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CRT-003
Identifier Type: -
Identifier Source: secondary_id
CRT-003
Identifier Type: -
Identifier Source: org_study_id
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