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

Phase 3

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00053820
• Lead Sponsor: Medical Research Council

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.

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2003-02-05
• Study First Submitted QC: 2003-02-05
• Study First Posted: 2003-02-06
• Status Verified: 2006-08
• Study Completion: 2006-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival

Secondary Outcome Measures

Name	Time	Method
Comparison of toxicity levels (Grade III and IV)
Comparison of quality of life before, during, after completion of study treatment
Time to progression as measured by RECIST criteria
Impact of the treatment regimens on health economics

Trial Locations

Locations (12)

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Onze Lieve Vrouw Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Academisch Ziekenhuis der Vrije Universiteit Brussel; 🇧🇪 Brussels, Belgium

Klinikum Kassel; 🇩🇪 Kassel, Germany

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Erasmus MC - Sophia Children's Hospital; 🇳🇱 Rotterdam, Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen; 🇳🇱 Nijmegen, Netherlands

University Medical Center Rotterdam at Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

National Cancer Institute - Bratislava; 🇸🇰 Bratislava, Slovakia