Interleukin-2, Interferon Alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00053807
First received: February 5, 2003
Last updated: September 20, 2012
Last verified: September 2012
  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 and interleukin-2 with fluorouracil may kill any remaining tumor cells following surgery. It is not yet known whether combining interferon alfa and interleukin-2 with fluorouracil is more effective than observation after surgery for kidney cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combining interleukin-2, interferon alfa, and fluorouracil to that of observation alone in treating patients who have undergone surgery for kidney cancer and are at high risk of relapse.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Biological: recombinant interferon alfa
Drug: fluorouracil
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Interleukin-2, Interferon-alpha and 5-Fluorouracil for Patients With High Risk of Relapse After Surgical Treatment for Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 96
Study Start Date: February 1998
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the effect of adjuvant combination therapy comprising interleukin-2, interferon alfa, and fluorouracil vs observation only on disease-free survival or overall survival of patients with renal cell carcinoma at high risk of relapse after radical surgery.
  • Compare the quality of life of patients treated with these regimens.

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

  • Arm I: Patients receive interleukin-2 subcutaneously (SC) on days 3, 4, and 5 of weeks 1 and 4 and on days 1, 3, and 5 of weeks 2 and 3. Patients also receive interferon alfa SC once weekly during weeks 1 and 4 and 3 times weekly during weeks 2, 3, 5, 6, 7, and 8. Patients then receive fluorouracil IV on day 1 of weeks 5, 6, 7, and 8.
  • Arm II (control arm): Patients receive no adjuvant treatment before disease progression.

Quality of life is assessed at baseline and at 2 and 6 months after randomization.

Patients are followed monthly for 3 months (arm I only), every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary renal cell carcinoma meeting 1 of the following criteria:

    • Stage T3b, T3c, or T4 tumor
    • Any pT stage and nodal status pN 1 or 2
    • Any pT stage and microscopic positive margins
    • Presence of any microscopic vascular invasion
  • Underwent surgical resection of primary tumor within the past month

    • Removal of clinical N+ disease required
  • No evidence of metastatic disease
  • No evidence of macroscopic residual disease

PATIENT CHARACTERISTICS:

Age

  • 75 and under

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Liver function tests no greater than 1.25 times upper limit of normal (ULN)

Renal

  • Creatinine less than 1.5 times ULN

Cardiovascular

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

Other

  • Not pregnant or nursing
  • No prior or other concurrent malignancies that would preclude study therapy or comparisons
  • No other concurrent illness that would preclude study therapy
  • No concurrent active infections requiring antibiotic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No other concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No concurrent corticosteroids
  • No concurrent hormonal therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics
  • No prior major organ allografts

Other

  • No other concurrent investigational drugs, agents, or devices
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053807

Locations
Austria
Kaiser Franz Josef Hospital
Vienna, Austria, A-1100
Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, B-9300
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
AZ Groeninge - Campus St. Maarten
Kortrijk, Belgium, 8500
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Hungary
National Institute of Oncology
Budapest, Hungary, 1125
Israel
Rambam Medical Center
Haifa, Israel, 30196
Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Netherlands
Akademisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Jeroen Bosch Ziekenhuis
Hertogenbosch, Netherlands, 5211 NL
University Medical Center Nijmegen
Nijmegen, Netherlands, 6500 HB
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, Netherlands, 3075 EA
Academisch Ziekenhuis Utrecht
Utrecht, Netherlands, 3584 CX
Turkey
Marmara University Hospital
Istanbul, Turkey, 81190
Dokuz Eylul University School of Medicine
Izmir, Turkey, 35340
United Kingdom
Beatson Institute for Cancer Research - Glasgow
Glasgow, Scotland, United Kingdom, G61 1BD
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
University of Glasgow
Investigators
Study Chair: Pieter H. M. de Mulder, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
Study Chair: Hein van Poppel, MD, PhD U.Z. Gasthuisberg
Study Chair: Paul A. Vasey, MD Beatson Institute for Cancer Research - Glasgow
  More Information

Additional Information:
No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00053807     History of Changes
Other Study ID Numbers: EORTC-30955, EORTC-30955
Study First Received: February 5, 2003
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III renal cell cancer
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
Interferon Alfa-2a
Interferons
Aldesleukin
Fluorouracil
Interleukin-2
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites

ClinicalTrials.gov processed this record on April 23, 2014