Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075452
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine hydrochloride Drug: oxaliplatin Phase 3

Detailed Description:



  • Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.


  • Compare the time of response in patients treated with these regimens.
  • Compare the clinical benefit of and tolerance to these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

Quality of life is assessed at baseline and then every 2 months.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
Study Start Date : November 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Time to response
  2. Clinical benefit
  3. Quality of life
  4. Progression-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed pancreatic adenocarcinoma

    • Locally advanced or metastatic disease
    • Unresectable disease
  • Measurable disease

    • At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
  • No adenocarcinoma of the bile ducts or ampulla of Vater
  • No known brain metastases



  • 18 to 75

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks


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


  • Bilirubin less than 1.5 times normal
  • Alkaline phosphatase less than 5 times normal


  • Creatinine less than 1.5 times normal
  • No uncontrolled or persistent hypercalcemia


  • No serious cardiac failure


  • No serious respiratory failure


  • Pain must be stabilized or controlled before initiation of study treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other untreatable malignant tumor
  • No serious psychological, familial, social, or geographical condition that would preclude study participation
  • No neuropathy that would preclude study participation


Biologic therapy

  • Not specified


  • No prior chemotherapy

Endocrine therapy

  • No concurrent corticosteroids except for antiemetic therapy


  • No prior radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00075452

Centre Paul Papin
Angers, France, 49036
C.H.G. Beauvais
Beauvais, France, 60021
Hopital Saint Andre
Bordeaux, France, 33075
CHU Ambroise Pare
Boulogne Billancourt, France, F-92104
CMC Bligny
Briis Sous Forges, France, 91640
Hopital Louis Pasteur
Chartres, France, 28018
Chu-Hopital Gabriel Montpied
Clermont Ferrand, France, F-63000
Hopital Beaujon
Clichy, France, 92118
Hopital Louis Mourier
Colombes, France, F-92701
Hopital Drevon
Dijon, France, 21000
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Hopital Saint - Louis
La Rochelle, France, 17000
Centre Hospitalier de Lagny
Lagny Sur Marne, France, 77405
Hopital Andre Mignot
Le Chesnay, France, 78157
Centre Jean Bernard
Le Mans, France, 72000
C. H. Du Mans
Le Mans, France, 72037
Hopital Robert Boulin
Libourne, France, 33500
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Clinique Saint Jean
Lyon, France, 69008
Hopital de la Croix Rousse
Lyon, France, 69317
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Intercommunal Hospital
Montfermeil, France, 93370
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital de la Croix St. Simon
Paris, France, 75020
Hopital Saint-Louis
Paris, France, 75475
Hopital Saint Antoine
Paris, France, 75571
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Tenon
Paris, France, 75970
Maison Medicale Marzet
Pau, France, 64000
Hopital Haut Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Clinique Ste - Marie
Pontoise, France, 95300
Polyclinique De Courlancy
Reims, France, F-51100
C. H. De Saumur
Saumur, France, 49403
C.H. Senlis
Senlis, France, 60309
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
OverallOfficial: Christophe Louvet, MD, PhD Hopital Saint Antoine

Publications of Results:
Other Publications: Identifier: NCT00075452     History of Changes
Other Study ID Numbers: CDR0000346480
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: May 2007

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs