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

Last updated: July 23, 2008
Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
Overall Status: Trial Status Unknown

Phase

3

Condition

Pancreatic Cancer

Pancreatitis

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT00075452
CDR0000346480
EU-20324
FRE-GERCOR-GEM-GEMOX/D00-3
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • ECOG 0-2 OR

  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

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

  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin less than 1.5 times normal

  • Alkaline phosphatase less than 5 times normal

Renal

  • Creatinine less than 1.5 times normal

  • No uncontrolled or persistent hypercalcemia

Cardiovascular

  • No serious cardiac failure

Pulmonary

  • No serious respiratory failure

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No concurrent corticosteroids except for antiemetic therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

Study Design

Study Start date:
November 01, 2003
Estimated Completion Date:

Study Description

OBJECTIVES:

Primary

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

Secondary

  • 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.

Connect with a study center

  • Centre Paul Papin

    Angers, 49036
    France

    Site Not Available

  • C.H.G. Beauvais

    Beauvais, 60021
    France

    Site Not Available

  • Hopital Saint Andre

    Bordeaux, 33075
    France

    Site Not Available

  • CHU Ambroise Pare

    Boulogne Billancourt, F-92104
    France

    Site Not Available

  • CMC Bligny

    Briis Sous Forges, 91640
    France

    Site Not Available

  • Hopital Louis Pasteur

    Chartres, 28018
    France

    Site Not Available

  • Chu-Hopital Gabriel Montpied

    Clermont Ferrand, F-63000
    France

    Site Not Available

  • Hopital Beaujon

    Clichy, 92118
    France

    Site Not Available

  • Hopital Louis Mourier

    Colombes, F-92701
    France

    Site Not Available

  • Hopital Drevon

    Dijon, 21000
    France

    Site Not Available

  • Centre Hospitalier Departemental

    La Roche Sur Yon, F-85025
    France

    Site Not Available

  • Hopital Saint - Louis

    La Rochelle, 17000
    France

    Site Not Available

  • Centre Hospitalier de Lagny

    Lagny Sur Marne, 77405
    France

    Site Not Available

  • Hopital Andre Mignot

    Le Chesnay, 78157
    France

    Site Not Available

  • C. H. Du Mans

    Le Mans, 72037
    France

    Site Not Available

  • Centre Jean Bernard

    Le Mans, 72000
    France

    Site Not Available

  • Hopital Robert Boulin

    Libourne, 33500
    France

    Site Not Available

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037
    France

    Site Not Available

  • Clinique Saint Jean

    Lyon, 69008
    France

    Site Not Available

  • Hopital de la Croix Rousse

    Lyon, 69317
    France

    Site Not Available

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038
    France

    Site Not Available

  • Intercommunal Hospital

    Montfermeil, 93370
    France

    Site Not Available

  • American Hospital of Paris

    Neuilly Sur Seine, F-92202
    France

    Site Not Available

  • CHU Pitie-Salpetriere

    Paris, 75651
    France

    Site Not Available

  • Hopital Bichat - Claude Bernard

    Paris, 75018
    France

    Site Not Available

  • Hopital Europeen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris, 75571
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris, 75475
    France

    Site Not Available

  • Hopital Tenon

    Paris, 75970
    France

    Site Not Available

  • Hopital de la Croix St. Simon

    Paris, 75020
    France

    Site Not Available

  • Maison Medicale Marzet

    Pau, 64000
    France

    Site Not Available

  • Hopital Haut Leveque

    Pessac, 33604
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • Clinique Ste - Marie

    Pontoise, 95300
    France

    Site Not Available

  • Polyclinique De Courlancy

    Reims, F-51100
    France

    Site Not Available

  • C. H. De Saumur

    Saumur, 49403
    France

    Site Not Available

  • C.H. Senlis

    Senlis, 60309
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, F-94805
    France

    Site Not Available

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