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

Primary Purpose

Carcinoma, Renal Cell

Status

Completed

Phase

Phase 2

Locations

Russian Federation

Study Type

Interventional

Intervention

capecitabine, interferon-alpha

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring kidney cancer, capecitabine, interferon

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

N.N. Blokhin Russian Cancer Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

All patients will receive capecitabine and interferon-alpha.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the safety and tolerability of the capecitabine and interferon combination

Evaluate response rate and overall survival with the capecitabine and interferon combination in MRCC pts with progression on IL-2 based regimens

Full Information

NCT ID

NCT00591188

First Posted

December 28, 2007

Last Updated

April 30, 2009

Sponsor

Kidney Cancer Research Bureau

1. Study Identification

Unique Protocol Identification Number

NCT00591188

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Kidney Cancer Research Bureau

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

Keywords

kidney cancer, capecitabine, interferon

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

All patients will receive capecitabine and interferon-alpha.

Intervention Type

Drug

Intervention Name(s)

capecitabine, interferon-alpha

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Evaluate the safety and tolerability of the capecitabine and interferon combination

Time Frame

one year

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilya V. Tsimafeyeu, MD

Organizational Affiliation

Kidney Cancer Research Bureau

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lev V. Demidov, MD, DSc.

Organizational Affiliation

N.N. Blokhin Russian Cancer Research Bureau

Official's Role

Study Director

Facility Information:

Facility Name

N.N. Blokhin Russian Cancer Research Center

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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