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

NCT ID: NCT00053820

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 670 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2006-12-31

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.

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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

recombinant interferon alfa

Intervention Type: BIOLOGICAL

fluorouracil

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: collaborator

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Martin E. Gore, MD

Role:

Royal Marsden NHS Foundation Trust

Peter F.A. Mulders, MD, PhD

Role:

Universitair Medisch Centrum St. Radboud - Nijmegen

Locations

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, , Belgium

Institut Jules Bordet

Brussels, , Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

Klinikum Kassel

Kassel, , Germany

Leiden University Medical Center

Leiden, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, , Netherlands

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, , Netherlands

Erasmus MC - Sophia Children's Hospital

Rotterdam, , Netherlands

National Cancer Institute - Bratislava

Bratislava, , Slovakia

Countries

Belgium; Germany; Netherlands; Slovakia

References

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.

Reference Type: RESULT

PMID: 20153039 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

MRC-RE04

Identifier Type: -

Identifier Source: secondary_id

EORTC-30012

Identifier Type: -

Identifier Source: secondary_id

EU-20231

Identifier Type: -

Identifier Source: secondary_id

ISRCTN46518965

Identifier Type: -

Identifier Source: secondary_id

CDR0000269480

Identifier Type: -

Identifier Source: org_study_id