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

Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Quality of life
Time to response
Clinical benefit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Christophe Louvet, MD, PhD, Hopital Saint Antoine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 11, 2004

First Posted (Estimate)

January 12, 2004

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

May 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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