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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allgemeines Krankenhaus der Stadt Wien
  • U.Z. Gasthuisberg
  • National Cancer Institute of Egypt
  • Institut Gustave Roussy
  • PZB - Praxenzentrum
  • Kreiskrankenhaus Aurich
  • Haematology-Oncology
  • Humaine Klinik Dresden GmbH
  • Medizinische Klinik I
  • Universitaetsklinik Duesseldorf
  • St. Johannes Hospital - Medical Klinik II
  • Hans-Susemihl-Krankenhaus
  • Haemato-Onkol. Praxis
  • Universitaetsklinik und Strahlenklinik - Essen
  • Kliniken Essen-Mitte
  • Klinikum Frankfurt (Oder)
  • Klinikum der J.W. Goethe Universitaet
  • Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Marien Hospital
  • Allgemeines Krankenhaus Hagen
  • Martin Luther Universitaet
  • Internistisch - Onkologische Gemeinschaftspraxis
  • Hermann-Holthusen Institute for Radiotherapy
  • Haematologisch-Onkologische Praxis Altona
  • Evangelische Krankenhaus Hamm
  • Henriettenstiftung - Chirurgische Klinik
  • Krankenhaus Siloah - Medizinische Klinik II
  • Medizinische Hochschule Hannover
  • Marienhospital/Ruhr University Bochum
  • Universitatsklinik, Saarland
  • Haematologisch-Oncologische Praxis
  • Klinikum Lippe-Lemgo
  • Stift Bethlehem
  • Staedtisches Klinikum Magdeburg
  • Otto-Von-Guericke-Universitaet Magdeburg
  • Johannes Gutenberg University
  • Muenchen Onkol. Praxis Elisenhof
  • Praxis Innere Medizin
  • Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover
  • Klinikum Nurnberg
  • Klinikum Ernst Von Bergmann
  • Klinikum D. Ch. Erxleben
  • Kreiskrankenhaus Riesa
  • University of Rostock
  • Fachkrankenhaus Marienstift
  • Katharinenhospital
  • Eberhard Karls Universitaet
  • Klinikum der Universitaet Ulm
  • Harz-Klinikum Wernigerode GMBH - Medizinische Klinik
  • Klinikum der Stadt Wolfsburg
  • Gemeinschaftspraxis
  • Medizinische Poliklinik, Universitaet Wuerzburg
  • Witten University - Klinikum Wuppertal
  • Ospedale San Lazzaro
  • Saint Laurentius Ziekenhuis
  • Russian Academy of Medical Sciences Cancer Research Center
  • Medical Oncology Centre of Rosebank

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00004885
Brief Title
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
Official Title
CPT-11 in Combination With Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Relative to Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Alone in Patients With Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Compare the efficacy and toxicity of high-dose fluorouracil and leucovorin calcium with or without irinotecan in patients with metastatic adenocarcinoma of the colon or rectum. II. Compare progression-free survival, overall survival, response rate, and duration of response in patients treated with these 2 regimens. III. Compare quality of life of patients treated with these 2 regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Arm II: Patients receive irinotecan IV over 30 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV over 24 hours on days 1, 8, 15, 22, 29, and 36. Treatment in both arms repeats every 7 weeks in the absence of disease progression or unacceptable toxicity. Patients in arm I who develop disease progression begin second-line therapy comprising irinotecan, fluorouracil, and leucovorin calcium within 2 months of progression. Patients with complete response are taken off study after receiving treatment for one year. Quality of life is assessed before beginning study, after completion of each course, at 4 weeks after completion of study, and then every 2 months until disease progression or death. Patients are followed every 2 months until disease progression or death. PROJECTED ACCRUAL: A total of 430 patients (215 per arm) will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus-Henning Koehne, MD
Organizational Affiliation
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Official's Role
Study Chair
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
PZB - Praxenzentrum
City
Aachen
ZIP/Postal Code
D-52062
Country
Germany
Facility Name
Kreiskrankenhaus Aurich
City
Aurich
ZIP/Postal Code
D-26603
Country
Germany
Facility Name
Haematology-Oncology
City
Braunschweig
ZIP/Postal Code
D-38100
Country
Germany
Facility Name
Humaine Klinik Dresden GmbH
City
Dresden
ZIP/Postal Code
01326
Country
Germany
Facility Name
Medizinische Klinik I
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Universitaetsklinik Duesseldorf
City
Duesseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
St. Johannes Hospital - Medical Klinik II
City
Duisburg
ZIP/Postal Code
D-47166
Country
Germany
Facility Name
Hans-Susemihl-Krankenhaus
City
Emden
ZIP/Postal Code
D-26721
Country
Germany
Facility Name
Haemato-Onkol. Praxis
City
Essen
ZIP/Postal Code
45127
Country
Germany
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Kliniken Essen-Mitte
City
Essen
ZIP/Postal Code
D-45136
Country
Germany
Facility Name
Klinikum Frankfurt (Oder)
City
Frankfurt (Oder)
ZIP/Postal Code
D-15236
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
City
Greifswald
ZIP/Postal Code
D-17487
Country
Germany
Facility Name
Marien Hospital
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Allgemeines Krankenhaus Hagen
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Facility Name
Martin Luther Universitaet
City
Halle Saale
ZIP/Postal Code
DOH-0-6112
Country
Germany
Facility Name
Internistisch - Onkologische Gemeinschaftspraxis
City
Halle
ZIP/Postal Code
D-06110
Country
Germany
Facility Name
Hermann-Holthusen Institute for Radiotherapy
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis Altona
City
Hamburg
ZIP/Postal Code
D-22765
Country
Germany
Facility Name
Evangelische Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
DOH-5-9063
Country
Germany
Facility Name
Henriettenstiftung - Chirurgische Klinik
City
Hannover
ZIP/Postal Code
D-30171
Country
Germany
Facility Name
Krankenhaus Siloah - Medizinische Klinik II
City
Hannover
ZIP/Postal Code
D-30449
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Marienhospital/Ruhr University Bochum
City
Herne
ZIP/Postal Code
DOH-4-4625
Country
Germany
Facility Name
Universitatsklinik, Saarland
City
Homburg/Saar
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Haematologisch-Oncologische Praxis
City
Koblenz
ZIP/Postal Code
D-56068
Country
Germany
Facility Name
Klinikum Lippe-Lemgo
City
Lemgo
ZIP/Postal Code
D-32657
Country
Germany
Facility Name
Stift Bethlehem
City
Ludwigslust
ZIP/Postal Code
D-19288
Country
Germany
Facility Name
Staedtisches Klinikum Magdeburg
City
Magdeburg
ZIP/Postal Code
D-39002
Country
Germany
Facility Name
Otto-Von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
D-39120
Country
Germany
Facility Name
Johannes Gutenberg University
City
Mainz
ZIP/Postal Code
D-55131
Country
Germany
Facility Name
Muenchen Onkol. Praxis Elisenhof
City
Munich
ZIP/Postal Code
D-80335
Country
Germany
Facility Name
Praxis Innere Medizin
City
Neustadt
ZIP/Postal Code
D-01844
Country
Germany
Facility Name
Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover
City
Neustadt
ZIP/Postal Code
D-31533
Country
Germany
Facility Name
Klinikum Nurnberg
City
Nuremberg (Nurnberg)
ZIP/Postal Code
D-90419
Country
Germany
Facility Name
Klinikum Ernst Von Bergmann
City
Postdam
ZIP/Postal Code
D-14467
Country
Germany
Facility Name
Klinikum D. Ch. Erxleben
City
Quedlinburg
ZIP/Postal Code
D-06484
Country
Germany
Facility Name
Kreiskrankenhaus Riesa
City
Riesa
ZIP/Postal Code
D-01589
Country
Germany
Facility Name
University of Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Fachkrankenhaus Marienstift
City
Schwarzenberg
ZIP/Postal Code
D-08340
Country
Germany
Facility Name
Katharinenhospital
City
Stuttgart
ZIP/Postal Code
D-70174
Country
Germany
Facility Name
Eberhard Karls Universitaet
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Klinikum der Universitaet Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Harz-Klinikum Wernigerode GMBH - Medizinische Klinik
City
Wernigerode
ZIP/Postal Code
D-38843
Country
Germany
Facility Name
Klinikum der Stadt Wolfsburg
City
Wolfsburg
ZIP/Postal Code
D-38440
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Worms
ZIP/Postal Code
DOH-6-7547
Country
Germany
Facility Name
Medizinische Poliklinik, Universitaet Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97070
Country
Germany
Facility Name
Witten University - Klinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
D-42283
Country
Germany
Facility Name
Ospedale San Lazzaro
City
Alba
ZIP/Postal Code
12051
Country
Italy
Facility Name
Saint Laurentius Ziekenhuis
City
Roermond
ZIP/Postal Code
6043 CV
Country
Netherlands
Facility Name
Russian Academy of Medical Sciences Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Medical Oncology Centre of Rosebank
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
15939923
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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

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