Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
NCT ID: NCT00112658
Last Updated: 2021-03-08
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
342 participants
INTERVENTIONAL
2004-11-30
2010-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Folfirinox
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
Gemcitabine
gemcitabine hydrochloride
Interventions
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fluorouracil
gemcitabine hydrochloride
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Thierry Conroy, MD
Role: STUDY_CHAIR
Centre Alexis Vautrin
Locations
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Centre Hospitalier Universitaire d'Amiens
Amiens, , France
Hopital Duffaut
Avignon, , France
Centre Hospitalier General
Belfort, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Hopital Avicenne
Bobigny, , France
Hopital Saint Andre
Bordeaux, , France
Institut Bergonie
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
CHU de Caen
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
CHR Clermont Ferrand, Hotel Dieu
Clermont-Ferrand, , France
Hopitaux Civils de Colmar
Colmar, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Hopital Du Bocage
Dijon, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, , France
Clinique Saint Vincent
Épernay, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
CMC Les Ormeaux
Le Havre, , France
Centre Oscar Lambret
Lille, , France
Hopital Saint Vincent de Paul
Lille, , France
Polyclinique des Quatre Pavillons
Lormont, , France
Hopital de la Croix Rousse
Lyon, , France
Centre Leon Berard
Lyon, , France
Hopital Edouard Herriot - Lyon
Lyon, , France
Hopital Ambroise Pare
Marseille, , France
CHU de la Timone
Marseille, , France
CHU Nord
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , 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
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Bichat - Claude Bernard
Paris, , France
Hopital Saint Michel
Paris, , France
Centre Hospitalier de Perpignan
Perpignan, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Jean Godinot
Reims, , France
CHU - Robert Debre
Reims, , France
Centre Eugene Marquis
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Clinique Charcot
Sainte-Foy-lès-Lyon, , France
Centre Hospitalier de Semur en Auxois
Semur-en-Auxois, , France
Centre Paul Strauss
Strasbourg, , France
Hopital Universitaire Hautepierre
Strasbourg, , France
Centre Hospitalier de Tarbes
Tarbes, , France
Institut Claudius Regaud
Toulouse, , France
CHU de Tours
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
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.
Other Identifiers
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FRE-FNCLCC-ACCORD-11/0402
Identifier Type: -
Identifier Source: secondary_id
EU-20512
Identifier Type: -
Identifier Source: secondary_id
CDR0000430100
Identifier Type: -
Identifier Source: org_study_id
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