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Sponsors and Collaborators: |
Medical Research Council European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053820 |
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.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Biological: aldesleukin Biological: recombinant interferon alfa Drug: fluorouracil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
Estimated Enrollment: | 670 |
Study Start Date: | July 2002 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 18 Years to 81 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Belgium | |
Academisch Ziekenhuis der Vrije Universiteit Brussel | |
Brussels, Belgium, 1090 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
Onze Lieve Vrouw Ziekenhuis Aalst | |
Aalst, Belgium, B-9300 | |
U.Z. Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Universitair Ziekenhuis Antwerpen | |
Edegem, Belgium, B-2650 | |
Germany | |
Klinikum Kassel | |
Kassel, Germany, D-34125 | |
Netherlands | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands, 6202 AZ | |
Erasmus MC - Sophia Children's Hospital | |
Rotterdam, Netherlands, 3015 GJ | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 CA | |
Universitair Medisch Centrum St. Radboud - Nijmegen | |
Nijmegen, Netherlands, 6500 HB | |
University Medical Center Rotterdam at Erasmus Medical Center | |
Rotterdam, Netherlands, 3000 CA | |
Slovakia | |
National Cancer Institute - Bratislava | |
Bratislava, Slovakia, 833 10 |
Investigator: | Martin E. Gore, MD | Royal Marsden - London |
Investigator: | Peter F.A. Mulders, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
Study ID Numbers: | CDR0000269480, MRC-RE04, EORTC-30012, EU-20231, ISRCTN46518965 |
Study First Received: | February 5, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00053820 History of Changes |
Health Authority: | United States: Federal Government |
stage IV renal cell cancer |
Antimetabolites Urinary Tract Neoplasm Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Renal Cancer Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Analgesics Kidney Diseases Interferon-alpha Kidney Cancer |
Anti-HIV Agents Interferons Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Carcinoma Aldesleukin Analgesics, Non-Narcotic Interleukin-2 Fluorouracil Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Interferon Alfa-2a Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Anti-Retroviral Agents Urologic Diseases Sensory System Agents Kidney Neoplasms |
Therapeutic Uses Analgesics Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type Growth Substances Interferons Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Carcinoma |