Back to resultsCombination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the rectum, stage IV rectal cancer, stage IV colon cancer, adenocarcinoma of the colon, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum Metastatic disease Unresectable disease Measurable disease that is outside the field of prior irradiation No brain metastases PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Transaminases ≤ 5 times normal Bilirubin ≤ 1.5 times normal Alkaline phosphatase < 3 times normal (5 times normal if due to hepatic involvement) Creatinine clearance > 45 mL/min Life expectancy > 3 months No psychological, social, or geographical situation that would preclude study treatment No chronic diarrhea or enteropathy No coronary insufficiency or symptomatic cardiac disease No other malignancy unless curatively treated No contraindication to chemotherapy PRIOR CONCURRENT THERAPY: At least 6 months since prior adjuvant chemotherapy for the primary tumor No prior extensive resection No other concurrent anticancer therapy
Sites / Locations
- Centre Hospitalier d'Abbeville
- Centre Hospitalier D'Agen
- Centre hospitalier d'Alencon
- Clinique De Rochebelle
- Centre Hospitalier Universitaire d'Amiens
- Centre Hospitalier d'Annecy
- Institut Sainte Catherine
- Hopital Duffaut
- Centre Hospitalier de Blois
- Hopital Saint Andre
- Centre Hospitalier Docteur Duchenne
- Hopital Ambroise Pare
- C.H. Bourg En Bresse
- Centre Hospitalier Pierre Oudot
- Centre Hospitalier de Briey
- Centre Medical de Bligny
- Centre Hospitalier de Chalons-en-Champagne
- Centre hospitalier de Charleville Mezieres
- Centre Hospitalier de Chateaubriant
- Hopital Louis Pasteur
- Louis Mourier Hospital
- Centre Hospitalier Universitaire Henri Mondor
- Centre Hospitalier de Digne les Bains
- Hopital Du Bocage
- Centre Hospitalier de Dreux
- Centre Hospitalier Intercommunal St. Aubin les Elbeuf
- Clinique Saint Vincent
- CHU de Grenoble - Hopital Michallon
- Clinique Pasteur
- Centre Hospitalier de Haguenau
- Centre Hospitalier Departemental
- Centre Hospitalier Universitaire de Bicetre
- Hopital Perpetuel Secours
- Hopital Robert Boulin
- Centre Hospital Universitaire Hop Huriez
- Centre Hospital Regional Universitaire de Limoges
- Centre Hospitalier General
- Clinique Saint Jean
- Hopital Edouard Herriot - Lyon
- CHU de la Timone
- CHU Nord
- Centre Hospitalier de Martigues
- Centre Gray
- Centre Hospitalier de Meaux
- Centre Hospitalier General de Mont de Marsan
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- CHU de Nancy - Hopitaux de Brabois
- Centre Hospitalier de Nevers
- Hopital de l'Archet CHU de Nice
- C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
- Centre Hospitalier d'Orange
- Hopital d'Instruction des Armees du Val de Grace
- Hopital Europeen Georges Pompidou
- Hopital Bichat - Claude Bernard
- CHU Pitie-Salpetriere
- Hopital Cochin
- Hopital Tenon
- Centre Hospitalier - Pau
- Centre Hospitalier de Perpignan
- Hopital Haut Leveque
- Hopital Rene Dubos
- CHU - Robert Debre
- Polyclinique De Courlancy
- Centre Eugene Marquis
- Centre Hospitalier Universitaire de Rouen
- Pole Sante Sarthe et Loir Hopital Pierre Daguet
- Centre Rene Huguenin
- Hopital d'Instruction des Armees Begin
- Centre Hospitalier de Saint-Quentin
- Center Hospitalier de Sens
- Hopital Foch
- Centre Hospitalier Valence
- Nouvelle Clinique Generale
- Centre Hospitalier de Valenciennes
- Centre Hospitalier Intercommunal de la Haute-Saone
- Institut Gustave Roussy
- Centre Hospitalier de Vire
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
LV5FU2 classique
LV5FU2 classique + irinotécan
LV5FU2 simplifié
LV5FU2 simplifié+ irinotécan
Arm Description
LV5FU2 classique
LV5FU2 classique + irinotécan
LV5FU2 simplifié
LV5FU2 simplifié + irinotécan
Outcomes
Primary Outcome Measures
Progression Free Survival (survie sans progression)
survie sans progression
Secondary Outcome Measures
Overall Survival (survie globale)
survie globale
Full Information
NCT ID
NCT00303771
First Posted
March 15, 2006
Last Updated
May 27, 2016
Sponsor
Federation Francophone de Cancerologie Digestive
1. Study Identification
Unique Protocol Identification Number
NCT00303771
Brief Title
Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Official Title
Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .
Detailed Description
OBJECTIVES:
Primary
Compare the progression-free survival of elderly patients with unresectable metastatic colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising fluorouracil and leucovorin calcium with vs without irinotecan hydrochloride.
Secondary
Compare the tumor response rate and overall survival of patients treated with these regimens.
Compare the tolerability of these regimens in these patients.
Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter, prospective study. Patients are stratified according to participating center, gender, Karnofsky score (60-70% vs 80-90% vs 100%), associated comorbidities (Charlson Index 0 vs 1-2 vs 3+), age (75 to 79 years vs ≥ 80 years), alkaline phosphatase level (≤ 2 times normal vs > 2 times normal), and prior adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.
Arm II: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 and 2.
Arm III: Patients receive leucovorin calcium and fluorouracil as in arm I and irinotecan hydrochloride IV over 90 minutes on day 1.
Arm IV: Patients receive leucovorin calcium and fluorouracil as in arm II and irinotecan hydrochloride as in arm III.
In all arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Patients undergo surgery within 3-10 weeks after completing chemotherapy.
Quality of life is assessed at baseline and then every 2 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
adenocarcinoma of the rectum, stage IV rectal cancer, stage IV colon cancer, adenocarcinoma of the colon, recurrent colon cancer, recurrent rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LV5FU2 classique
Arm Type
Active Comparator
Arm Description
LV5FU2 classique
Arm Title
LV5FU2 classique + irinotécan
Arm Type
Experimental
Arm Description
LV5FU2 classique + irinotécan
Arm Title
LV5FU2 simplifié
Arm Type
Active Comparator
Arm Description
LV5FU2 simplifié
Arm Title
LV5FU2 simplifié+ irinotécan
Arm Type
Experimental
Arm Description
LV5FU2 simplifié + irinotécan
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Primary Outcome Measure Information:
Title
Progression Free Survival (survie sans progression)
Description
survie sans progression
Time Frame
2011
Secondary Outcome Measure Information:
Title
Overall Survival (survie globale)
Description
survie globale
Time Frame
2011
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon or rectum
Metastatic disease
Unresectable disease
Measurable disease that is outside the field of prior irradiation
No brain metastases
PATIENT CHARACTERISTICS:
Karnofsky performance status 60-100%
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Transaminases ≤ 5 times normal
Bilirubin ≤ 1.5 times normal
Alkaline phosphatase < 3 times normal (5 times normal if due to hepatic involvement)
Creatinine clearance > 45 mL/min
Life expectancy > 3 months
No psychological, social, or geographical situation that would preclude study treatment
No chronic diarrhea or enteropathy
No coronary insufficiency or symptomatic cardiac disease
No other malignancy unless curatively treated
No contraindication to chemotherapy
PRIOR CONCURRENT THERAPY:
At least 6 months since prior adjuvant chemotherapy for the primary tumor
No prior extensive resection
No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Mitry, MD, PhD
Organizational Affiliation
Hopital Ambroise Pare
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier d'Abbeville
City
Abbeville
ZIP/Postal Code
80101
Country
France
Facility Name
Centre Hospitalier D'Agen
City
Agen
ZIP/Postal Code
47923
Country
France
Facility Name
Centre hospitalier d'Alencon
City
Alencon
ZIP/Postal Code
61000
Country
France
Facility Name
Clinique De Rochebelle
City
Ales
ZIP/Postal Code
F-30100
Country
France
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier d'Annecy
City
Annecy
ZIP/Postal Code
74011 Cedex
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Hopital Duffaut
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Centre Hospitalier de Blois
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Hospitalier Docteur Duchenne
City
Boulogne Sur Mer
ZIP/Postal Code
62200
Country
France
Facility Name
Hopital Ambroise Pare
City
Boulogne-Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
C.H. Bourg En Bresse
City
Bourg En Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Centre Hospitalier Pierre Oudot
City
Bourgoin-Jallieu
ZIP/Postal Code
38300
Country
France
Facility Name
Centre Hospitalier de Briey
City
Briey
ZIP/Postal Code
54151
Country
France
Facility Name
Centre Medical de Bligny
City
Briis-Sous-Forges
ZIP/Postal Code
91640
Country
France
Facility Name
Centre Hospitalier de Chalons-en-Champagne
City
Chalons-en-Champagne
ZIP/Postal Code
51000
Country
France
Facility Name
Centre hospitalier de Charleville Mezieres
City
Charleville-Mezieres cedex
ZIP/Postal Code
08000
Country
France
Facility Name
Centre Hospitalier de Chateaubriant
City
Chateaubriant cedex
ZIP/Postal Code
44146
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Louis Mourier Hospital
City
Colombes Cedex
ZIP/Postal Code
92701
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Hospitalier de Digne les Bains
City
Digne Cedex
ZIP/Postal Code
04003
Country
France
Facility Name
Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Hospitalier de Dreux
City
Dreux
ZIP/Postal Code
28100
Country
France
Facility Name
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
City
Elbeuf
ZIP/Postal Code
76503
Country
France
Facility Name
Clinique Saint Vincent
City
Epernay
ZIP/Postal Code
51200
Country
France
Facility Name
CHU de Grenoble - Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Clinique Pasteur
City
Guilherand Granges
ZIP/Postal Code
07500
Country
France
Facility Name
Centre Hospitalier de Haguenau
City
Haguenau
ZIP/Postal Code
67504
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
Centre Hospitalier Universitaire de Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Hopital Perpetuel Secours
City
Levallois
ZIP/Postal Code
92309
Country
France
Facility Name
Hopital Robert Boulin
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Hospitalier General
City
Longjumeau
ZIP/Postal Code
91164
Country
France
Facility Name
Clinique Saint Jean
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Centre Hospitalier de Martigues
City
Martigues
ZIP/Postal Code
13698
Country
France
Facility Name
Centre Gray
City
Maubeuge
ZIP/Postal Code
59600
Country
France
Facility Name
Centre Hospitalier de Meaux
City
Meaux
ZIP/Postal Code
77104
Country
France
Facility Name
Centre Hospitalier General de Mont de Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
CHU de Nancy - Hopitaux de Brabois
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Centre Hospitalier de Nevers
City
Nevers
ZIP/Postal Code
58033
Country
France
Facility Name
Hopital de l'Archet CHU de Nice
City
Nice
ZIP/Postal Code
F-06202
Country
France
Facility Name
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Centre Hospitalier d'Orange
City
Orange
ZIP/Postal Code
84100
Country
France
Facility Name
Hopital d'Instruction des Armees du Val de Grace
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Centre Hospitalier - Pau
City
Pau
ZIP/Postal Code
64046
Country
France
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Rene Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
CHU - Robert Debre
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Centre Hospitalier Universitaire de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Pole Sante Sarthe et Loir Hopital Pierre Daguet
City
Sable Sur Sarthe
ZIP/Postal Code
72305
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Hopital d'Instruction des Armees Begin
City
Saint-Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Centre Hospitalier de Saint-Quentin
City
Saint-Quentin
ZIP/Postal Code
02321
Country
France
Facility Name
Center Hospitalier de Sens
City
Sens
ZIP/Postal Code
89108
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Centre Hospitalier Valence
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Nouvelle Clinique Generale
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Centre Hospitalier de Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
Centre Hospitalier Intercommunal de la Haute-Saone
City
Vesoul
ZIP/Postal Code
70000
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Centre Hospitalier de Vire
City
Vire
ZIP/Postal Code
14504
Country
France
12. IPD Sharing Statement
Citations:
Citation
Aparicio T, Jouve J, Teillet L, et al.: Geriatric factors to predict toxicity and dose-intensity reduction in FFCD 2001-02 phase III study comparing a first-line chemotherapy of LV5FU2 or FOLFIRI in treatment of metastatic colorectal cancer (mCRC) in elderly patients. [Abstract] J Clin Oncol 29 (Suppl 15): A-9111, 2011.
Results Reference
result
Citation
Mitry E, Phelip JM, Bonnetain F, et al.: Phase III trial of chemotherapy with or without irinotecan in the front-line treatment of metastatic colorectal cancer in elderly patients (FFCD 2001-02 trial): results of a planned interim analysis. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-281, 2008.
Results Reference
result
PubMed Identifier
26487578
Citation
Aparicio T, Lavau-Denes S, Phelip JM, Maillard E, Jouve JL, Gargot D, Gasmi M, Locher C, Adhoute X, Michel P, Khemissa F, Lecomte T, Provencal J, Breysacher G, Legoux JL, Lepere C, Charneau J, Cretin J, Chone L, Azzedine A, Bouche O, Sobhani I, Bedenne L, Mitry E; FFCD investigators. Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001-02). Ann Oncol. 2016 Jan;27(1):121-7. doi: 10.1093/annonc/mdv491. Epub 2015 Oct 20.
Results Reference
result
PubMed Identifier
23460711
Citation
Aparicio T, Jouve JL, Teillet L, Gargot D, Subtil F, Le Brun-Ly V, Cretin J, Locher C, Bouche O, Breysacher G, Charneau J, Seitz JF, Gasmi M, Stefani L, Ramdani M, Lecomte T, Mitry E. Geriatric factors predict chemotherapy feasibility: ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients. J Clin Oncol. 2013 Apr 10;31(11):1464-70. doi: 10.1200/JCO.2012.42.9894. Epub 2013 Mar 4.
Results Reference
result
Learn more about this trial
Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
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