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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00591188
Enrollment
49
Registered
2008-01-11
Start date
2006-12-31
Completion date
Unknown
Last updated
2009-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Renal Cell

Keywords

kidney cancer, capecitabine, interferon

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

Interventions

DRUGcapecitabine, interferon-alpha

Patients who meet inclusion/exclusion criteria will receive combination of study drugs.

Sponsors

Kidney Cancer Research Bureau
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-lineone year

Secondary

MeasureTime frame
Evaluate the safety and tolerability of the capecitabine and interferon combinationone year
Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimensone year

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026