Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
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.
Biological: recombinant interferon alfa
|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|
- Survival [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||July 2002|
|Study Completion Date:||December 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053820
|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|
|Leuven, Belgium, B-3000|
|Kassel, Germany, D-34125|
|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|
|Erasmus MC - Sophia Children's Hospital|
|Rotterdam, Netherlands, 3015 GJ|
|University Medical Center Rotterdam at Erasmus Medical Center|
|Rotterdam, Netherlands, 3000 CA|
|National Cancer Institute - Bratislava|
|Bratislava, Slovakia, 833 10|
|Investigator:||Martin E. Gore, MD||Royal Marsden NHS Foundation Trust|
|Investigator:||Peter F.A. Mulders, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|