Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens (NCT00591188)

01

Study 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

02

Conditions studied

Carcinoma, Renal Cell

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Keywords

kidney cancer, capecitabine, interferon

03

In context

Carcinoma, Renal Cell

1,992 studies on the registry are indexed under Carcinoma, Renal Cell; 387 are open to participants now.

This study's planned enrollment of 49 is above the median of 42 across 1,501 interventional studies indexed under Carcinoma, Renal Cell.

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Lead sponsor

Kidney Cancer Research Bureau is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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

05

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 49 participants (estimated)

Study arms

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

Interventions

Drugcapecitabine, interferon-alpha
Drug pages: Capecitabine · Interferon Alpha
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.

06

What researchers measure

Primary outcomes

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 outcomes

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

07

Study locations

1 site

N.N. Blokhin Russian Cancer Research Center
Moscow, 115478, Russia

08

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2006 and a primary completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 28, 2007
First posted: Jan 11, 2008
Start: Dec 2006
Primary completionActual: May 2008
Last update: May 1, 2009

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID: NCT00591188
Lead sponsor: Kidney Cancer Research Bureau
First posted: Jan 11, 2008
Start date: Dec 2006
Primary completion: May 2008
Last update: May 1, 2009

Study contacts

Ilya V. Tsimafeyeu, MD

principal investigator · Kidney Cancer Research Bureau

Lev V. Demidov, MD, DSc.

study director · N.N. Blokhin Russian Cancer Research Bureau

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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