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Pancreatic CancerPhase 2/3NCT00112658

Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

A Phase 2/3 study testing fluorouracil, gemcitabine hydrochloride and irinotecan hydrochloride in people with Pancreatic Cancer, run by UNICANCER at 55 sites in France.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy 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) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
fluorouracil, gemcitabine hydrochloride and irinotecan hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
55 sitesFrance
Study dates
Nov 2004to 30 Jun 2010
Phase
Phase 2/3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • No other pancreatic tumor type, including either of the following:
  • Neuroendocrine tumor
  • Acinar cell tumor
  • Metastatic disease
  • Measurable disease in an area not previously irradiated
  • No cerebral metastases or meningeal involvement of the tumor

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed)

Renal

  • Creatinine < 120 mmol/L

Cardiovascular

  • No prior myocardial infarction
  • No prior angina
  • No uncompensated cardiac or coronary insufficiency
  • No symptomatic arrhythmia

Gastrointestinal

  • No prior inflammatory bowel disease
  • No prior chronic diarrhea
  • No unresolved symptomatic occlusion or subocclusion of the bowel

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No ongoing active infection
  • No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to study treatment
  • No other serious medical disorder that would preclude study treatment
  • No psychiatric disorder or social or geographic situation that would preclude study participation
  • Not detained or under the guardianship of another person

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Other

  • No concurrent participation in another clinical trial using therapeutic experimental agents

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

France55 sites

  • Centre Hospitalier Universitaire d'Amiens

    Amiens, 80054

  • Hopital Duffaut

    Avignon, 84902

  • Centre Hospitalier General

    Belfort, 90000

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Avicenne

    Bobigny, 93009

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Hopital Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • CHU de Caen

    Caen, 14033

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • CHR Clermont Ferrand, Hotel Dieu

    Clermont-Ferrand, 63058

  • Hopitaux Civils de Colmar

    Colmar, 68024

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Hopital Du Bocage

    Dijon, 21034

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier Intercommunal St. Aubin les Elbeuf

    Elbeuf, 76503

  • Clinique Saint Vincent

    Épernay, 51200

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • CMC Les Ormeaux

    Le Havre, 76600

  • Centre Oscar Lambret

    Lille, 59020

  • Hopital Saint Vincent de Paul

    Lille, F-59020

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • Hopital Ambroise Pare

    Marseille, 13291

  • CHU de la Timone

    Marseille, 13385

  • CHU Nord

    Marseille, 13915

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

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

    Montpellier, 34298

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint Michel

    Paris, 75674

  • Centre Hospitalier de Perpignan

    Perpignan, 66046

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Institut Jean Godinot

    Reims, 51056

  • CHU - Robert Debre

    Reims, 51092

  • Centre Eugene Marquis

    Rennes, 35064

  • Hopital Charles Nicolle

    Rouen, 76031

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Clinique Charcot

    Sainte-Foy-lès-Lyon, 69110

  • Centre Hospitalier de Semur en Auxois

    Semur-en-Auxois, 21140

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hopital Universitaire Hautepierre

    Strasbourg, 67098

  • Centre Hospitalier de Tarbes

    Tarbes, 65013

  • Institut Claudius Regaud

    Toulouse, 31052

  • CHU de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

RATIONALE: Drugs used in chemotherapy 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) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II)
  • Compare the survival of patients treated with these regimens. (Phase III)

Secondary

  • Compare the toxicity of these regimens in these patients.
  • Compare progression-free survival of patients treated with these regimens. (Phase III)
  • Compare the overall response rate in patients treated with these regimens. (Phase III)
  • Compare quality of life of patients treated with these regimens. (Phase III)

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days.
  • Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.

Keywords
adenocarcinoma of the pancreas, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

Study groups in NCT00112658
Study groupRoleWhat they receive
FolfirinoxExperimentalNot described
Receives: Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Drug: oxaliplatin
GemcitabineActive comparatorNot described
Receives: Drug: gemcitabine hydrochloride

What is being measured

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

  1. Objective response rate (Phase II)

  2. Survival (Phase III)

Secondary outcomes (4)

  1. Toxicity

  2. Progression-free survival (Phase III)

  3. Quality of life (Phase III)

  4. Overall response rate (Phase III)

Timeline

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

  1. First posted3 Jun 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionJun 2010
  4. Study completion30 Jun 2010

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112658
Sponsor's protocol ID
CDR0000430100
Other IDs
FRE-FNCLCC-ACCORD-11/0402, EU-20512
Status last verified
Mar 2021
First submitted
2 Jun 2005
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PubMed 21561347

  • Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of the ACCORD 11 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4516, 2007.

  • Lambert A, Jarlier M, Gourgou Bourgade S, Conroy T. Response to FOLFIRINOX by gender in patients with metastatic pancreatic cancer: Results from the PRODIGE 4/ ACCORD 11 randomized trial. PLoS One. 2017 Sep 20;12(9):e0183288. doi: 10.1371/journal.pone.0183288. eCollection 2017.

    PubMed 28931010

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing fluorouracil, gemcitabine hydrochloride and irinotecan hydrochloride in people with Pancreatic Cancer, run by UNICANCER at 55 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective response rate (Phase II). The study lists 2 primary outcomes in all. 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 NCT00112658, which also lists 3 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 8 Mar 2021.

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