NCT00053820

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
670

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2002

Typical duration for phase_3

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 19, 2013

Status Verified

August 1, 2006

First QC Date

February 5, 2003

Last Update Submit

December 18, 2013

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (4)

  • Time to progression as measured by RECIST criteria

  • Comparison of toxicity levels (Grade III and IV)

  • Comparison of quality of life before, during, after completion of study treatment

  • Impact of the treatment regimens on health economics

Interventions

aldesleukinBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
fluorouracilDRUG

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Advanced metastatic disease that requires treatment * Measurable disease (single bone lesions not included) * No brain metastasis PATIENT CHARACTERISTICS: Age * 18 to 81 Performance status * WHO 0-1 Life expectancy * More than 12 weeks Hematopoietic * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic * Not specified Renal * Not specified Cardiovascular * No myocardial infarction within the past 6 months * No unstable angina pectoris Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 6 months after study participation * No other concurrent disease or prior malignancy that would preclude study treatments or comparisons * No concurrent active infection requiring antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy Chemotherapy * No prior chemotherapy Endocrine therapy * No prior endocrine therapy * No concurrent corticosteroids Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Prior resection of the primary tumor recommended but not required * No prior major organ allografts

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (12)

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Klinikum Kassel

Kassel, D-34125, Germany

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Related Publications (2)

  • Gore ME, Griffin CL, Hancock B, Patel PM, Pyle L, Aitchison M, James N, Oliver RT, Mardiak J, Hussain T, Sylvester R, Parmar MK, Royston P, Mulders PF. Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomised trial. Lancet. 2010 Feb 20;375(9715):641-8. doi: 10.1016/S0140-6736(09)61921-8. Epub 2010 Feb 10.

    PMID: 20153039RESULT

  • Gore ME: Interferon-α (IFN), interleukin-2 (IL2) and 5-fluorouracil (5FU) vs IFN alone in patients with metastatic renal cell carcinoma (mRCC): results of the randomised MRC/EORTC RE04 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-5039, 2008.

    RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

aldesleukinInterferon-alphaFluorouracil

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Martin E. Gore, MD

    Royal Marsden NHS Foundation Trust

  • Peter F.A. Mulders, MD, PhD

    Universitair Medisch Centrum St. Radboud - Nijmegen

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

July 1, 2002

Study Completion

December 1, 2006

Last Updated

December 19, 2013

Record last verified: 2006-08

Locations

DE(1)SL(1)BE(5)NL(5)