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

This study has been completed.
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053820
First received: February 5, 2003
Last updated: December 18, 2013
Last verified: August 2006
  Purpose

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 Intervention Phase
Kidney Cancer
Biological: aldesleukin
Biological: recombinant interferon alfa
Drug: fluorouracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression as measured by RECIST criteria [ Designated as safety issue: No ]
  • Comparison of toxicity levels (Grade III and IV) [ Designated as safety issue: Yes ]
  • Comparison of quality of life before, during, after completion of study treatment [ Designated as safety issue: No ]
  • Impact of the treatment regimens on health economics [ Designated as safety issue: No ]

Estimated Enrollment: 670
Study Start Date: July 2002
Study Completion Date: December 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053820

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, B-9300
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, Belgium, 1090
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Germany
Klinikum Kassel
Kassel, Germany, D-34125
Netherlands
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
Slovakia
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Sponsors and Collaborators
Medical Research Council
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Martin E. Gore, MD Royal Marsden NHS Foundation Trust
Investigator: Peter F.A. Mulders, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00053820     History of Changes
Other Study ID Numbers: CDR0000269480, MRC-RE04, EORTC-30012, EU-20231, ISRCTN46518965
Study First Received: February 5, 2003
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferons
Aldesleukin
Fluorouracil
Interleukin-2
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on August 19, 2014