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

April 30, 2009 updated by: Kidney Cancer Research Bureau

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115478
        • N.N. Blokhin Russian Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
All patients will receive capecitabine and interferon-alpha.
Drug: capecitabine, interferon-alpha
Patients who meet inclusion/exclusion criteria will receive combination of study drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the safety and tolerability of the capecitabine and interferon combination
Time Frame: one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kidney Cancer Research Bureau

Investigators

  • Principal Investigator: Ilya V. Tsimafeyeu, MD, Kidney Cancer Research Bureau
  • Study Director: Lev V. Demidov, MD, DSc., N.N. Blokhin Russian Cancer Research Bureau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

May 1, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRT-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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