search
Back to results

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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
fluorouracil
gemcitabine hydrochloride
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire d'Amiens
  • Hopital Duffaut
  • Centre Hospitalier General
  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
  • Hopital Avicenne
  • Hopital Saint Andre
  • Institut Bergonie
  • Polyclinique Bordeaux Nord Aquitaine
  • Centre Hospitalier Docteur Duchenne
  • Hopital Ambroise Pare
  • CHU de Caen
  • Centre Regional Francois Baclesse
  • Centre Jean Perrin
  • CHR Clermont Ferrand, Hotel Dieu
  • Hopitaux Civils de Colmar
  • Centre Hospitalier Universitaire Henri Mondor
  • Hopital Du Bocage
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • Centre Hospitalier Intercommunal St. Aubin les Elbeuf
  • Clinique Saint Vincent
  • Centre Hospitalier Departemental
  • CMC Les Ormeaux
  • Centre Oscar Lambret
  • Hopital Saint Vincent de Paul
  • Polyclinique des Quatre Pavillons
  • Hopital de la Croix Rousse
  • Centre Leon Berard
  • Hopital Edouard Herriot - Lyon
  • Hopital Ambroise Pare
  • CHU de la Timone
  • CHU Nord
  • Hopital Notre-Dame de Bon Secours
  • Centre Hospitalier General de Mont de Marsan
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Regional Rene Gauducheau
  • CHR D'Orleans - Hopital de la Source
  • Hopital Bichat - Claude Bernard
  • Hopital Saint Michel
  • Centre Hospitalier de Perpignan
  • Centre Hospitalier Lyon Sud
  • Institut Jean Godinot
  • CHU - Robert Debre
  • Centre Eugene Marquis
  • Hopital Charles Nicolle
  • Clinique Armoricaine De Radiologie
  • Centre Rene Huguenin
  • Clinique Charcot
  • Centre Hospitalier de Semur en Auxois
  • Centre Paul Strauss
  • Hopital Universitaire Hautepierre
  • Centre Hospitalier de Tarbes
  • Institut Claudius Regaud
  • CHU de Tours
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Folfirinox

Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate (Phase II)
Survival (Phase III)

Secondary Outcome Measures

Toxicity
Progression-free survival (Phase III)
Quality of life (Phase III)
Overall response rate (Phase III)

Full Information

First Posted
June 2, 2005
Last Updated
March 5, 2021
Sponsor
UNICANCER
search

1. Study Identification

Unique Protocol Identification Number
NCT00112658
Brief Title
Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2004 (Actual)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 30, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Folfirinox
Arm Type
Experimental
Arm Title
Gemcitabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Objective response rate (Phase II)
Title
Survival (Phase III)
Secondary Outcome Measure Information:
Title
Toxicity
Title
Progression-free survival (Phase III)
Title
Quality of life (Phase III)
Title
Overall response rate (Phase III)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Conroy, MD
Organizational Affiliation
Centre Alexis Vautrin
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Duffaut
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Centre Hospitalier General
City
Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Centre Hospitalier Docteur Duchenne
City
Boulogne Sur Mer
ZIP/Postal Code
62200
Country
France
Facility Name
Hopital Ambroise Pare
City
Boulogne-Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CHR Clermont Ferrand, Hotel Dieu
City
Clermont-Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
Hopitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
City
Elbeuf
ZIP/Postal Code
76503
Country
France
Facility Name
Clinique Saint Vincent
City
Epernay
ZIP/Postal Code
51200
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
CMC Les Ormeaux
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hopital Saint Vincent de Paul
City
Lille
ZIP/Postal Code
F-59020
Country
France
Facility Name
Polyclinique des Quatre Pavillons
City
Lormont
ZIP/Postal Code
33310
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hopital Ambroise Pare
City
Marseille
ZIP/Postal Code
13291
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHU Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Centre Hospitalier General de Mont de Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Saint Michel
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
CHU - Robert Debre
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35064
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Clinique Charcot
City
Sainte Foy Les Lyon
ZIP/Postal Code
69110
Country
France
Facility Name
Centre Hospitalier de Semur en Auxois
City
Semur en Auxois
ZIP/Postal Code
21140
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Hopital Universitaire Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Centre Hospitalier de Tarbes
City
Tarbes
ZIP/Postal Code
65013
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21561347
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
28931010
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs