Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

NCT00303771 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000453855FFCD-2001-02EU-20546AVENTIS-FFCD-2001-02PFIZER-FFCD-2001-02
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 77

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 .

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (survie sans progression)

  survie sans progression

  2011

Secondary Outcomes (1)

• Overall Survival (survie globale)

  2011

Study Arms (4)

LV5FU2 classique

ACTIVE COMPARATOR

LV5FU2 classique

Drug: fluorouracil; Drug: leucovorin calcium

LV5FU2 classique + irinotécan

EXPERIMENTAL

LV5FU2 classique + irinotécan

Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

LV5FU2 simplifié

ACTIVE COMPARATOR

LV5FU2 simplifié

Drug: fluorouracil; Drug: leucovorin calcium

LV5FU2 simplifié+ irinotécan

EXPERIMENTAL

LV5FU2 simplifié + irinotécan

Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

Interventions

fluorouracil DRUG

LV5FU2 classique; LV5FU2 classique + irinotécan; LV5FU2 simplifié; LV5FU2 simplifié+ irinotécan

irinotecan hydrochloride DRUG

LV5FU2 classique + irinotécan; LV5FU2 simplifié+ irinotécan

leucovorin calcium DRUG

LV5FU2 classique; LV5FU2 classique + irinotécan; LV5FU2 simplifié; LV5FU2 simplifié+ irinotécan

Eligibility Criteria

• Age: 75 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

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

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (77)

Centre Hospitalier d'Abbeville

Abbeville, 80101, France

Location

Centre Hospitalier D'Agen

Agen, 47923, France

Location

Centre hospitalier d'Alencon

Alençon, 61000, France

Location

Clinique De Rochebelle

Alès, F-30100, France

Location

Centre Hospitalier Universitaire d'Amiens

Amiens, 80054, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Institut Sainte Catherine

Avignon, 84000, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Centre Hospitalier de Blois

Blois, 41016, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

C.H. Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

Centre Hospitalier de Briey

Briey, 54151, France

Location

Centre Medical de Bligny

Briis-sous-Forges, 91640, France

Location

Centre hospitalier de Charleville Mezieres

Charleville-Mézières, 08000, France

Location

Centre Hospitalier de Chalons-en-Champagne

Châlons-en-Champagne, 51000, France

Location

Centre Hospitalier de Chateaubriant

Châteaubriant, 44146, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Louis Mourier Hospital

Colombes, 92701, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Centre Hospitalier de Digne les Bains

Digne-les-Bains, 04003, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre Hospitalier de Dreux

Dreux, 28100, France

Location

Centre Hospitalier Intercommunal St. Aubin les Elbeuf

Elbeuf, 76503, France

Location

Clinique Saint Vincent

Épernay, 51200, France

Location

CHU de Grenoble - Hopital Michallon

Grenoble, 38043, France

Location

Clinique Pasteur

Guilherand-Granges, 07500, France

Location

Centre Hospitalier de Haguenau

Haguenau, 67504, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Centre Hospitalier Universitaire de Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Hopital Perpetuel Secours

Levallois-Perret, 92309, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Hospitalier General

Longjumeau, 91164, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CHU Nord

Marseille, 13915, France

Location

Centre Hospitalier de Martigues

Martigues, 13698, France

Location

Centre Gray

Maubeuge, 59600, France

Location

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CHU de Nancy - Hopitaux de Brabois

Nancy, 54035, France

Location

Centre Hospitalier de Nevers

Nevers, 58033, France

Location

Hopital de l'Archet CHU de Nice

Nice, F-06202, France

Location

C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

Nîmes, 30029, France

Location

Centre Hospitalier d'Orange

Orange, 84100, France

Location

Hopital d'Instruction des Armees du Val de Grace

Paris, 75005, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier - Pau

Pau, 64046, France

Location

Centre Hospitalier de Perpignan

Perpignan, 66046, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Hopital Rene Dubos

Pontoise, 95300, France

Location

CHU - Robert Debre

Reims, 51092, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Centre Hospitalier Universitaire de Rouen

Rouen, 76031, France

Location

Pole Sante Sarthe et Loir Hopital Pierre Daguet

Sablé-sur-Sarthe, 72305, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Hopital d'Instruction des Armees Begin

Saint-Mandé, 94160, France

Location

Centre Hospitalier de Saint-Quentin

Saint-Quentin, 02321, France

Location

Center Hospitalier de Sens

Sens, 89108, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Centre Hospitalier Valence

Valence, 26000, France

Location

Nouvelle Clinique Generale

Valence, 26000, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59322, France

Location

Centre Hospitalier Intercommunal de la Haute-Saone

Vesoul, 70000, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Centre Hospitalier de Vire

Vire, 14504, France

Location

Related Publications (4)

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 26487578 RESULT

• 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.

  PMID: 23460711 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms; Colonic 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

• Emmanuel Mitry, MD, PhD

  Hopital Ambroise Pare

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: June 1, 2003
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 30, 2016

Record last verified: 2016-05

Locations

FR (77)