Clinical trial · Interventional
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
NCT00591188CI-TRIAL-00002274completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine, interferon-alpha | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- All patients will receive capecitabine and interferon-alpha.
- interventionNames
- Drug: capecitabine, interferon-alpha
Primary outcomes (1)
- measure
- Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line
- timeFrame
- one year
Secondary outcomes (2)
- measure
- Evaluate the safety and tolerability of the capecitabine and interferon combination
- timeFrame
- one year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.