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Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2006
Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112658
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
 Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
 Phase II
Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Gemcitabine hydrochloride Gemcitabine Fluorouracil Oxaliplatin Calcium gluconate Pancrelipase Ultrase
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (Phase II) [ Designated as safety issue: No ]
  • Survival (Phase III) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Progression-free survival (Phase III) [ Designated as safety issue: No ]
  • Quality of life (Phase III) [ Designated as safety issue: No ]
  • Overall response rate (Phase III) [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112658

Locations
France
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Thierry Conroy, MD     33-3-8359-8460        
Centre Eugene Marquis Recruiting
Rennes, France, 35064
Contact: J.L. Raoul, MD, PhD     33-2-9925-3000     raoul@rennes.fnlcc.fr    
Centre Hospitalier de Perpignan Recruiting
Perpignan, France, 66046
Contact: Faiza Khemissa-Akouz, PhD     33-4-6861-6633        
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Ulrich Stein, MD     33-81-668-240        
Centre Hospitalier Universitaire Henri Mondor Recruiting
Creteil, France, 94000
Contact: Pascal Piedbois, MD, PhD     33-1-4981-2582     pascal.piedbois@hmm.ap-hop-paris.fr    
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Philippe Chollet, MD, PhD     33-4-7327-8198     philippe.chollet@cjp.fr    
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Francoise Desseigne     33-4-78-78-26-45        
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Antoine Adenis, MD, PhD     33-320-29-59-42     a-adenis@o-lambret.fr    
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD     33-4-6761-3066     mychou@valdorel.fnclcc.fr    
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Marie-Pierre Galais     33-2-3145-5000        
Centre Regional Rene Gauducheau Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Jaafar Bennouna     33-2-40-479-959        
Polyclinique des Quatre Pavillons Recruiting
Lormont, France, 33310
Contact: Pierre Guichard, MD     33-5-5780-8467        
CHU - Robert Debre Recruiting
Reims, France, 51092
Contact: Olivier Bouche, MD, PhD     33-3-2678-7169     obouche@chu-reims.fr    
CHU de Caen Recruiting
Caen, France, 14033
Contact: Dominique Arsene     33-2-3106-7409        
CHU de Tours Recruiting
Tours, France, 37044
Contact: Thierry Lecomte, MD     33-2-4747-5900     lecomt.t@med.univ-tours.fr    
Hopital Avicenne Recruiting
Bobigny, France, 93009
Contact: Gaetan Des Guetz, MD     33-1-4895-5033        
Hopital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Pierre Michel     33-2-3288-8260        
Hopital Saint Joseph Recruiting
Paris, France, 75674
Contact: Gael Deplanque, MD, MSC, PhD     33-1-4412-7626     gdeplanque@hpsj.fr    
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Yves Becouarn, MD     33-5-56-333-242     becouarn@bergonie.org    
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Rosine Guimbaud     33-5-6142-4242        
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Michel Ducreux, MD, PhD     33-1-4211-4308     ducreux@igr.fr    
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Salvador Nasca, MD     33-03-2650-4444        
Centre Rene Huguenin Recruiting
Saint Cloud, France, 92210
Contact: Frederique B. Cvitkovic, MD     33-1-4711-1824     f.cvitkovic@stcloud-huguenin.org    
Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer
Investigators
Study Chair: Thierry Conroy, MD Centre Alexis Vautrin
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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.

Study ID Numbers: CDR0000430100, FRE-FNCLCC-ACCORD-11/0402, EU-20512
Study First Received: June 2, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00112658  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Irinotecan
Endocrine System Diseases
Leucovorin
Pancrelipase
Camptothecin
Calcium, Dietary
Oxaliplatin
 Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
 Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamins
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009



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