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)

December 20, 2005
December 22, 2005
May 27, 2008
September 2004
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Objective response rate
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Complete list of historical versions of study NCT00268411 on Archive Site
  • Clinical benefits and tolerability
  • Progression-free and overall survival
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Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]

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.



  • 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.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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GERCOR - Multidisciplinary Oncology Cooperative Group
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Study Chair: Christophe Louvet, MD, PhD Hopital Saint Antoine
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP