Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer

NCT00004885 | Completed Phase 3

• 1 other identifier: EORTC-40986
• Study Type: interventional
• Target: 430
• Locations: 9 countries
• Sites: 57

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Interventions

FOLFIRI regimen DRUG

fluorouracil DRUG

irinotecan hydrochloride DRUG

leucovorin calcium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the colon or rectum Measurable or evaluable disease outside of any prior radiation port No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if liver metastasis present) AST and ALT no greater than 3 times ULN (5 times ULN if liver metastasis present) Renal: Creatinine no greater than 1.25 times ULN Cardiovascular: No severe cardiac disease No uncontrolled angina pectoris No myocardial infarction within the past 6 months Gastrointestinal: No unresolved bowel obstruction or subobstruction No uncontrolled Crohn's disease or ulcerative colitis No history of chronic diarrhea Other: No second malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer No other uncontrolled severe medical condition Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease No prior adjuvant chemotherapy containing topoisomerase I inhibitors At least 6 months since other prior adjuvant chemotherapy Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics Surgery: Not specified Other: At least 4 weeks since other prior investigational drugs No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (57)

Allgemeines Krankenhaus der Stadt Wien

Vienna, A-1090, Austria

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

PZB - Praxenzentrum

Aachen, D-52062, Germany

Location

Kreiskrankenhaus Aurich

Aurich, D-26603, Germany

Location

Haematology-Oncology

Braunschweig, D-38100, Germany

Location

Humaine Klinik Dresden GmbH

Dresden, 01326, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

St. Johannes Hospital - Medical Klinik II

Duisburg, D-47166, Germany

Location

Universitaetsklinik Duesseldorf

Düsseldorf, D-40225, Germany

Location

Hans-Susemihl-Krankenhaus

Emden, D-26721, Germany

Location

Haemato-Onkol. Praxis

Essen, 45127, Germany

Location

Universitaetsklinik und Strahlenklinik - Essen

Essen, D-45122, Germany

Location

Kliniken Essen-Mitte

Essen, D-45136, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Klinikum Frankfurt (Oder)

Frankfurt (Oder), D-15236, Germany

Location

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17487, Germany

Location

Marien Hospital

Hagen, 58095, Germany

Location

Allgemeines Krankenhaus Hagen

Hagen, D-58095, Germany

Location

Internistisch - Onkologische Gemeinschaftspraxis

Halle, D-06110, Germany

Location

Martin Luther Universitaet

Halle, DOH-0-6112, Germany

Location

Hermann-Holthusen Institute for Radiotherapy

Hamburg, D-20099, Germany

Location

Haematologisch-Onkologische Praxis Altona

Hamburg, D-22765, Germany

Location

Evangelische Krankenhaus Hamm

Hamm, DOH-5-9063, Germany

Location

Henriettenstiftung - Chirurgische Klinik

Hanover, D-30171, Germany

Location

Krankenhaus Siloah - Medizinische Klinik II

Hanover, D-30449, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Marienhospital/Ruhr University Bochum

Herne, DOH-4-4625, Germany

Location

Universitatsklinik, Saarland

Homburg/Saar, D-66421, Germany

Location

Haematologisch-Oncologische Praxis

Koblenz, D-56068, Germany

Location

Klinikum Lippe-Lemgo

Lemgo, D-32657, Germany

Location

Stift Bethlehem

Ludwigslust, D-19288, Germany

Location

Staedtisches Klinikum Magdeburg

Magdeburg, D-39002, Germany

Location

Otto-Von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

Location

Johannes Gutenberg University

Mainz, D-55131, Germany

Location

Muenchen Onkol. Praxis Elisenhof

Munich, D-80335, Germany

Location

Praxis Innere Medizin

Neustadt, D-01844, Germany

Location

Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover

Neustadt, D-31533, Germany

Location

Klinikum Nurnberg

Nuremberg (Nurnberg), D-90419, Germany

Location

Klinikum Ernst Von Bergmann

Postdam, D-14467, Germany

Location

Klinikum D. Ch. Erxleben

Quedlinburg, D-06484, Germany

Location

Kreiskrankenhaus Riesa

Riesa, D-01589, Germany

Location

University of Rostock

Rostock, 18057, Germany

Location

Fachkrankenhaus Marienstift

Schwarzenberg, D-08340, Germany

Location

Katharinenhospital

Stuttgart, D-70174, Germany

Location

Eberhard Karls Universitaet

Tübingen, D-72076, Germany

Location

Klinikum der Universitaet Ulm

Ulm, D-89081, Germany

Location

Harz-Klinikum Wernigerode GMBH - Medizinische Klinik

Wernigerode, D-38843, Germany

Location

Klinikum der Stadt Wolfsburg

Wolfsburg, D-38440, Germany

Location

Gemeinschaftspraxis

Worms, DOH-6-7547, Germany

Location

Witten University - Klinikum Wuppertal

Wuppertal, D-42283, Germany

Location

Medizinische Poliklinik, Universitaet Wuerzburg

Würzburg, D-97070, Germany

Location

Ospedale San Lazzaro

Alba, 12051, Italy

Location

Saint Laurentius Ziekenhuis

Roermond, 6043 CV, Netherlands

Location

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

Location

Medical Oncology Centre of Rosebank

Johannesburg, 2193, South Africa

Location

Related Publications (3)

• Kohne CH, van Cutsem E, Wils J, Bokemeyer C, El-Serafi M, Lutz MP, Lorenz M, Reichardt P, Ruckle-Lanz H, Frickhofen N, Fuchs R, Mergenthaler HG, Langenbuch T, Vanhoefer U, Rougier P, Voigtmann R, Muller L, Genicot B, Anak O, Nordlinger B; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol. 2005 Aug 1;23(22):4856-65. doi: 10.1200/JCO.2005.05.546. Epub 2005 Jun 6.

  PMID: 15939923 RESULT

• Kohne CH, Van Custem E, Wils JA, et al.: Irinotecan improves the activity of the AIO regimen in metastatic colorectal cancer: results of EORTC GI Group study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1018, 2003.

  RESULT

• Kohne C, van Cutsem E, Wils J, et al.: Weekly high dose infusional 5-FU plus folinic acid (FA) with or without irinotecan (IRI) in metastatic colorectal cancer (MCRC): interim safety results of EORTC study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-532, 2002.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Claus-Henning Koehne, MD

  Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: April 12, 2004
• Study Start: July 1, 1999
• Primary Completion: July 1, 2001
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

DE (49); ZA (1); EG (1); FR (1); IT (1); RU (1); BE (1); NL (1); AU (1)