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Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer

18. december 2013 opdateret af: Medical Research Council

A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma

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.

Studieoversigt

Status

Afsluttet

Betingelser

Nyrekræft

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Compare progression-free and overall survival of patients with advanced metastatic renal carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil.
Compare the toxicity of these regimens in these patients.
Assess the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence of disease progression or unacceptable toxicity.
Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3, 5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks 1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.

Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

670

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Belgien
- - Aalst, Belgien, B-9300
    - Onze Lieve Vrouw Ziekenhuis Aalst
  - Brussels, Belgien, 1000
    - Institut Jules Bordet
  - Brussels, Belgien, 1090
    - Academisch Ziekenhuis der Vrije Universiteit Brussel
  - Edegem, Belgien, B-2650
    - Universitair Ziekenhuis Antwerpen
  - Leuven, Belgien, B-3000
    - U.Z. Gasthuisberg
Holland
- - Leiden, Holland, 2300 CA
    - Leiden University Medical Center
  - Maastricht, Holland, 6202 AZ
    - Academisch Ziekenhuis Maastricht
  - Nijmegen, Holland, 6500 HB
    - Universitair Medisch Centrum St. Radboud - Nijmegen
  - Rotterdam, Holland, 3000 CA
    - University Medical Center Rotterdam at Erasmus Medical Center
  - Rotterdam, Holland, 3015 GJ
    - Erasmus MC - Sophia Children's Hospital
Slovakiet
- - Bratislava, Slovakiet, 833 10
    - National Cancer Institute - Bratislava
Tyskland
- - Kassel, Tyskland, D-34125
    - Klinikum Kassel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 81 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Overlevelse

Sekundære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical Research Council

Samarbejdspartnere

European Organisation for Research and Treatment of Cancer - EORTC

Efterforskere

Martin E. Gore, MD, Royal Marsden NHS Foundation Trust
Peter F.A. Mulders, MD, PhD, Universitair Medisch Centrum St. Radboud - Nijmegen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.
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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2002

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

5. februar 2003

Først indsendt, der opfyldte QC-kriterier