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Colorectal CancerPhase 3NCT00303771

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

A Phase 3 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 77 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 75 to 120 years
Conditions the study is for
Colorectal Cancer
What is being tested?
fluorouracil, irinotecan hydrochloride and leucovorin calcium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
77 sitesFrance
Study dates
Jun 2003to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 to 120 years
  • All sexes
  • No healthy volunteers
  • Older adult

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

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

France77 sites

  • Centre Hospitalier d'Abbeville

    Abbeville, 80101

  • Centre Hospitalier D'Agen

    Agen, 47923

  • Centre hospitalier d'Alencon

    Alençon, 61000

  • Clinique De Rochebelle

    Alès, F-30100

  • Centre Hospitalier Universitaire d'Amiens

    Amiens, 80054

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Institut Sainte Catherine

    Avignon, 84000

  • Hopital Duffaut

    Avignon, 84902

  • Centre Hospitalier de Blois

    Blois, 41016

  • Hopital Saint Andre

    Bordeaux, 33075

  • Hopital Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • C.H. Bourg En Bresse

    Bourg-en-Bresse, 01012

  • Centre Hospitalier Pierre Oudot

    Bourgoin, 38300

  • Centre Hospitalier de Briey

    Briey, 54151

  • Centre Medical de Bligny

    Briis-sous-Forges, 91640

  • Centre Hospitalier de Chalons-en-Champagne

    Châlons-en-Champagne, 51000

  • Centre hospitalier de Charleville Mezieres

    Charleville-Mézières, 08000

  • Centre Hospitalier de Chateaubriant

    Châteaubriant, 44146

  • Hopital Louis Pasteur

    Colmar, 68024

  • Louis Mourier Hospital

    Colombes, 92701

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Centre Hospitalier de Digne les Bains

    Digne-les-Bains, 04003

  • Hopital Du Bocage

    Dijon, 21034

  • Centre Hospitalier de Dreux

    Dreux, 28100

  • Centre Hospitalier Intercommunal St. Aubin les Elbeuf

    Elbeuf, 76503

  • Clinique Saint Vincent

    Épernay, 51200

  • CHU de Grenoble - Hopital Michallon

    Grenoble, 38043

  • Clinique Pasteur

    Guilherand-Granges, 07500

  • Centre Hospitalier de Haguenau

    Haguenau, 67504

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Centre Hospitalier Universitaire de Bicetre

    Le Kremlin-Bicêtre, 94275

  • Hopital Perpetuel Secours

    Levallois-Perret, 92309

  • Hopital Robert Boulin

    Libourne, 33500

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Hospitalier General

    Longjumeau, 91164

  • Clinique Saint Jean

    Lyon, 69008

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • CHU de la Timone

    Marseille, 13385

  • CHU Nord

    Marseille, 13915

  • Centre Hospitalier de Martigues

    Martigues, 13698

  • Centre Gray

    Maubeuge, 59600

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

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

    Montpellier, 34298

  • CHU de Nancy - Hopitaux de Brabois

    Nancy, 54035

  • Centre Hospitalier de Nevers

    Nevers, 58033

  • Hopital de l'Archet CHU de Nice

    Nice, F-06202

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

    Nîmes, 30029

  • Centre Hospitalier d'Orange

    Orange, 84100

  • Hopital d'Instruction des Armees du Val de Grace

    Paris, 75005

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Hopital Cochin

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Centre Hospitalier - Pau

    Pau, 64046

  • Centre Hospitalier de Perpignan

    Perpignan, 66046

  • Hopital Haut Leveque

    Pessac, 33604

  • Hopital Rene Dubos

    Pontoise, 95300

  • CHU - Robert Debre

    Reims, 51092

  • Polyclinique De Courlancy

    Reims, F-51100

  • Centre Eugene Marquis

    Rennes, 35064

  • Centre Hospitalier Universitaire de Rouen

    Rouen, 76031

  • Pole Sante Sarthe et Loir Hopital Pierre Daguet

    Sablé-sur-Sarthe, 72305

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Hopital d'Instruction des Armees Begin

    Saint-Mandé, 94160

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02321

  • Center Hospitalier de Sens

    Sens, 89108

  • Hopital Foch

    Suresnes, 92151

  • Centre Hospitalier Valence

    Valence, 26000

  • Nouvelle Clinique Generale

    Valence, 26000

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59322

  • Centre Hospitalier Intercommunal de la Haute-Saone

    Vesoul, 70000

  • Institut Gustave Roussy

    Villejuif, F-94805

  • Centre Hospitalier de Vire

    Vire, 14504

Other trials in France

About this study

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

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 .

Read the 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.

Keywords
adenocarcinoma of the rectum, stage IV rectal cancer, stage IV colon cancer, adenocarcinoma of the colon, recurrent colon cancer, recurrent rectal cancer
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00303771
Study groupRoleWhat they receive
LV5FU2 classiqueActive comparatorLV5FU2 classique
Receives: Drug: fluorouracil; Drug: leucovorin calcium
LV5FU2 classique + irinotécanExperimentalLV5FU2 classique + irinotécan
Receives: Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium
LV5FU2 simplifiéActive comparatorLV5FU2 simplifié
Receives: Drug: fluorouracil; Drug: leucovorin calcium
LV5FU2 simplifié+ irinotécanExperimentalLV5FU2 simplifié + irinotécan
Receives: Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (survie sans progression)

    survie sans progression

    Measured: 2011

Secondary outcomes (1)

  1. Overall Survival (survie globale)

    survie globale

    Measured: 2011

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startJun 2003
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303771
Sponsor's protocol ID
CDR0000453855
Other IDs
FFCD-2001-02, EU-20546, AVENTIS-FFCD-2001-02, PFIZER-FFCD-2001-02
Status last verified
May 2016
First submitted
15 Mar 2006
Last updated
30 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26487578

  • 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.

    PubMed 23460711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluorouracil, irinotecan hydrochloride and leucovorin calcium in people with Colorectal Cancer, run by Federation Francophone de Cancerologie Digestive at 77 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (survie sans progression) (time frame: 2011). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303771, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.

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