Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

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: NCT00268411
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2005
Last Update Posted : May 27, 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 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 whether giving both of these drugs on the same day is more effective than giving them on different days.

PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.

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

Detailed Description:



  • Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.


  • Compare the clinical benefits and tolerability of these regimens in these patients.
  • Compare the progression-free and overall survival of patients treated with these regimens.

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

  • Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.

In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Objective response rate

Secondary Outcome Measures :
  1. Clinical benefits and tolerability
  2. Progression-free and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the pancreas

    • Metastatic disease
  • Measurable disease (primary tumor or metastasis)

    • At least 1 cm in diameter by spiral CT scan
  • No ampulla of Vater carcinoma or biliary adenocarcinoma
  • No known brain metastases


  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • Life expectancy more than 12 weeks
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Alkaline phosphatase < 5 times normal
  • Bilirubin < 1.5 times normal
  • Creatinine < 1.5 times normal
  • No pre-existing neuropathy
  • No unstable or uncontrolled pain
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No serious cardiovascular disease
  • No serious respiratory disease
  • No uncontrolled or persistent hypercalcemia
  • No psychological, familial, social, or geographical condition that would preclude study treatment
  • No other active malignancy


  • No prior chemotherapy or radiotherapy
  • No concurrent corticosteroids

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): NCT00268411

Hopital Duffaut
Avignon, France, 84902
C.H.G. Beauvais
Beauvais, France, 60021
Hopital Drevon
Dijon, France, 21000
Centre Hospitalier de Dreux
Dreux, France, 28100
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Hopital Saint - Louis
La Rochelle, France, 17000
Hopital Louis Pasteur - Le Coudray
Le Coudray, France, 28630
Clinique Victor Hugo
Le Mans, France, F-72000
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Clinique Saint Jean
Lyon, France, 69008
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Polyclinique De Courlancy
Reims, France, F-51100
C.H. Senlis
Senlis, France, 60309
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Christophe Louvet, MD, PhD Hopital Saint Antoine Identifier: NCT00268411     History of Changes
Other Study ID Numbers: CDR0000453849
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: May 27, 2008
Last Verified: May 2007

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
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