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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053820
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : December 19, 2013
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: aldesleukin Biological: recombinant interferon alfa Drug: fluorouracil Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma
Study Start Date : July 2002
Actual Study Completion Date : December 2006

Primary Outcome Measures :
  1. Survival

Secondary Outcome Measures :
  1. Time to progression as measured by RECIST criteria
  2. Comparison of toxicity levels (Grade III and IV)
  3. Comparison of quality of life before, during, after completion of study treatment
  4. Impact of the treatment regimens on health economics

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed renal cell carcinoma

    • Advanced metastatic disease that requires treatment
  • Measurable disease (single bone lesions not included)
  • No brain metastasis



  • 18 to 81

Performance status

  • WHO 0-1

Life expectancy

  • More than 12 weeks


  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 10 g/dL


  • Not specified


  • Not specified


  • No myocardial infarction within the past 6 months
  • No unstable angina pectoris


  • 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


Biologic therapy

  • No prior biologic therapy


  • No prior chemotherapy

Endocrine therapy

  • No prior endocrine therapy
  • No concurrent corticosteroids


  • At least 4 weeks since prior radiotherapy


  • Prior resection of the primary tumor recommended but not required
  • No prior major organ allografts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053820

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Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, B-9300
Institut Jules Bordet
Brussels, Belgium, 1000
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Klinikum Kassel
Kassel, Germany, D-34125
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, 6500 HB
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands, 3015 GJ
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Sponsors and Collaborators
Medical Research Council
European Organisation for Research and Treatment of Cancer - EORTC
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OverallOfficial: Martin E. Gore, MD Royal Marsden NHS Foundation Trust
OverallOfficial: Peter F.A. Mulders, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen

Publications of Results:
Layout table for additonal information Identifier: NCT00053820    
Other Study ID Numbers: CDR0000269480
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: August 2006
Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents