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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591188
• Other study ID #: CRT-003
• Secondary ID: CRT-003
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2007
• Last updated: April 30, 2009
• Start date: December 2006

Study information

• Verified date: April 2009
• Source: Kidney Cancer Research Bureau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• capecitabine, interferon-alpha
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin Russian Cancer Research Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate progression-free survival with capecitabine and interferon treatment in metastatic renal cell carcinoma (MRCC) patients (pts) with IL-2 failure in first-line		one year	No
Secondary	Evaluate the safety and tolerability of the capecitabine and interferon combination		one year	Yes
Secondary	Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens		one year	Yes

External Links

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