Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 81	Other	MRC-RE04 EORTC-30012, EU-20231, ISRCTN46518965, NCT00053820, RE04

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed renal cell carcinoma
  • Advanced metastatic disease that requires treatment



• Measurable disease (single bone lesions not included)



• No brain metastasis

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

Patient Characteristics:

Age

• 18 to 81

Performance status

• WHO 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Survival

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

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.

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Martin Gore, MD, Study coordinator		Ph: 44-20-7808-2198 Email: martin.gore@rmh.nhs.uk

European Organization for Research and Treatment of Cancer

Peter Mulders, MD, PhD, Study coordinator		Ph: 31-24-361-0871

Registry Information
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
Trial Start Date		2002-07-23
Registered in ClinicalTrials.gov		NCT00053820
Date Submitted to PDQ		2002-11-27
Information Last Verified		2006-08-15

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