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

NCT00112658 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000430100FRE-FNCLCC-ACCORD-11/0402EU-20512
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 55

Brief 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. 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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate (Phase II)

• Survival (Phase III)

Secondary Outcomes (4)

• Toxicity

• Progression-free survival (Phase III)

• Quality of life (Phase III)

• Overall response rate (Phase III)

Study Arms (2)

Folfirinox

EXPERIMENTAL

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

Gemcitabine

ACTIVE COMPARATOR

Drug: gemcitabine hydrochloride

Interventions

fluorouracil DRUG

Folfirinox

gemcitabine hydrochloride DRUG

Gemcitabine

irinotecan hydrochloride DRUG

Folfirinox

leucovorin calcium DRUG

Folfirinox

oxaliplatin DRUG

Folfirinox

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (55)

Centre Hospitalier Universitaire d'Amiens

Amiens, 80054, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Centre Hospitalier General

Belfort, 90000, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Hopital Avicenne

Bobigny, 93009, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHR Clermont Ferrand, Hotel Dieu

Clermont-Ferrand, 63058, France

Location

Hopitaux Civils de Colmar

Colmar, 68024, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Intercommunal St. Aubin les Elbeuf

Elbeuf, 76503, France

Location

Clinique Saint Vincent

Épernay, 51200, France

Location

Centre Hospitalier Departemental

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

Location

CMC Les Ormeaux

Le Havre, 76600, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hopital Saint Vincent de Paul

Lille, F-59020, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot - Lyon

Lyon, 69437, France

Location

Hopital Ambroise Pare

Marseille, 13291, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CHU Nord

Marseille, 13915, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, 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

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Saint Michel

Paris, 75674, France

Location

Centre Hospitalier de Perpignan

Perpignan, 66046, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

CHU - Robert Debre

Reims, 51092, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Clinique Charcot

Sainte-Foy-lès-Lyon, 69110, France

Location

Centre Hospitalier de Semur en Auxois

Semur-en-Auxois, 21140, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Centre Hospitalier de Tarbes

Tarbes, 65013, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

CHU de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (3)

• 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.

  PMID: 21561347 RESULT

• 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.

  RESULT

• 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.

  PMID: 28931010 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Thierry Conroy, MD

  Centre Alexis Vautrin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: November 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 30, 2010
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

FR (55)