Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
NCT ID: NCT00303771
Last Updated: 2016-05-30
Study Results
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Basic Information
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COMPLETED
PHASE3
282 participants
INTERVENTIONAL
2003-06-30
2011-01-31
Brief Summary
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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 .
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LV5FU2 classique
LV5FU2 classique
fluorouracil
leucovorin calcium
LV5FU2 classique + irinotécan
LV5FU2 classique + irinotécan
fluorouracil
irinotecan hydrochloride
leucovorin calcium
LV5FU2 simplifié
LV5FU2 simplifié
fluorouracil
leucovorin calcium
LV5FU2 simplifié+ irinotécan
LV5FU2 simplifié + irinotécan
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Interventions
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fluorouracil
irinotecan hydrochloride
leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
120 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Emmanuel Mitry, MD, PhD
Role: STUDY_CHAIR
Hopital Ambroise Pare
Locations
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Centre Hospitalier d'Abbeville
Abbeville, , France
Centre Hospitalier D'Agen
Agen, , France
Centre hospitalier d'Alencon
Alençon, , France
Clinique De Rochebelle
Alès, , France
Centre Hospitalier Universitaire d'Amiens
Amiens, , France
Centre Hospitalier d'Annecy
Annecy, , France
Institut Sainte Catherine
Avignon, , France
Hopital Duffaut
Avignon, , France
Centre Hospitalier de Blois
Blois, , France
Hopital Saint Andre
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
C.H. Bourg En Bresse
Bourg-en-Bresse, , France
Centre Hospitalier Pierre Oudot
Bourgoin, , France
Centre Hospitalier de Briey
Briey, , France
Centre Medical de Bligny
Briis-sous-Forges, , France
Centre hospitalier de Charleville Mezieres
Charleville-Mézières, , France
Centre Hospitalier de Chalons-en-Champagne
Châlons-en-Champagne, , France
Centre Hospitalier de Chateaubriant
Châteaubriant, , France
Hopital Louis Pasteur
Colmar, , France
Louis Mourier Hospital
Colombes, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Centre Hospitalier de Digne les Bains
Digne-les-Bains, , France
Hopital Du Bocage
Dijon, , France
Centre Hospitalier de Dreux
Dreux, , France
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, , France
Clinique Saint Vincent
Épernay, , France
CHU de Grenoble - Hopital Michallon
Grenoble, , France
Clinique Pasteur
Guilherand-Granges, , France
Centre Hospitalier de Haguenau
Haguenau, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Hospitalier Universitaire de Bicetre
Le Kremlin-Bicêtre, , France
Hopital Perpetuel Secours
Levallois-Perret, , France
Hopital Robert Boulin
Libourne, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Centre Hospitalier General
Longjumeau, , France
Clinique Saint Jean
Lyon, , France
Hopital Edouard Herriot - Lyon
Lyon, , France
CHU de la Timone
Marseille, , France
CHU Nord
Marseille, , France
Centre Hospitalier de Martigues
Martigues, , France
Centre Gray
Maubeuge, , France
Centre Hospitalier de Meaux
Meaux, , France
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
CHU de Nancy - Hopitaux de Brabois
Nancy, , France
Centre Hospitalier de Nevers
Nevers, , France
Hopital de l'Archet CHU de Nice
Nice, , France
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
Nîmes, , France
Centre Hospitalier d'Orange
Orange, , France
Hopital d'Instruction des Armees du Val de Grace
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Cochin
Paris, , France
Hopital Tenon
Paris, , France
Centre Hospitalier - Pau
Pau, , France
Centre Hospitalier de Perpignan
Perpignan, , France
Hopital Haut Leveque
Pessac, , France
Hopital Rene Dubos
Pontoise, , France
CHU - Robert Debre
Reims, , France
Polyclinique De Courlancy
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Hospitalier Universitaire de Rouen
Rouen, , France
Pole Sante Sarthe et Loir Hopital Pierre Daguet
Sablé-sur-Sarthe, , France
Centre Rene Huguenin
Saint-Cloud, , France
Hopital d'Instruction des Armees Begin
Saint-Mandé, , France
Centre Hospitalier de Saint-Quentin
Saint-Quentin, , France
Center Hospitalier de Sens
Sens, , France
Hopital Foch
Suresnes, , France
Centre Hospitalier Valence
Valence, , France
Nouvelle Clinique Generale
Valence, , France
Centre Hospitalier de Valenciennes
Valenciennes, , France
Centre Hospitalier Intercommunal de la Haute-Saone
Vesoul, , France
Institut Gustave Roussy
Villejuif, , France
Centre Hospitalier de Vire
Vire, , France
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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FFCD-2001-02
Identifier Type: -
Identifier Source: secondary_id
EU-20546
Identifier Type: -
Identifier Source: secondary_id
AVENTIS-FFCD-2001-02
Identifier Type: -
Identifier Source: secondary_id
PFIZER-FFCD-2001-02
Identifier Type: -
Identifier Source: secondary_id
CDR0000453855
Identifier Type: -
Identifier Source: org_study_id
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