Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

February 6, 2009 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit, in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this regimen in this patient population. III. Determine the survival without disease progression in patients treated with this regimen. IV. Determine the overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or may undergo surgical resection. Fluorouracil-based chemotherapy (with or without radiotherapy) may then resume after surgery. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

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

  • France
      • Ales, France, F-30100
        • Clinique De Rochebelle
      • Argenteuil, France, 95107
        • Centre Hospitalier Victor Dupouy
      • Bayonne, France, F-64100
        • Centre D'Oncologie Du Pays-Basqu
      • Beauvais, France, 60021
        • C.H.G. Beauvais
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Briis Sous Forges, France, 91640
        • CMC Bligny
      • Cagne-sur-Mer, France, 06800
        • Clinique Saint-Jean
      • Chartres, France, 28018
        • Hopital Fontenoy
      • Clichy, France, 92118
        • Hôpital Beaujon
      • Dijon, France, 21000
        • Hopital Drevon
      • Dunkerque, France, 59240
        • Centre d'Oncologie Dunkerquois
      • Fontaineblea, France, 7300
        • Polyclinique De La Foret
      • Grenoble, France, 38043
        • Chr De Grenoble - La Tronche
      • LA Seyne Sur Me, France, 83500
        • Clinique du Cap d'Or
      • La Garenne Colombes, France, 92250
        • Centre De Charlebourg
      • Le Chesnay, France, 78157
        • Hôpital André Mignot
      • Lyon, France, 69317
        • Hopital de la croix rousse
      • Marseille, France, 13274
        • Assistance Publique Hopitaux de Marseille Hopitaux Sud
      • Metz, France, 55038
        • Hopital Notre-Dame de Bon Secours
      • Metz, France, 57070
        • Hôpital Clinique Claude Bernard
      • Montfermeil, France, 93370
        • Intercommunal Hospital
      • Moulins, France, 03006 Cedex
        • Centre Hospitalier de Moulins Yzeure
      • Mulhouse, France, 68051
        • Centre Hospitalier de Mulhouse
      • Nantes, France, 44093
        • CHR Hotel Dieu
      • Neuilly Sur Seine, France, F-92202
        • American Hospital of Paris
      • Orleans, France, 45067
        • CHR D'Orleans - Hopital de la Source
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75014
        • Hôpital Saint Joseph
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 75475
        • Hôpital Saint-Louis
      • Paris, France, 75012
        • Hôpital Rothschild
      • Paris, France, 75007
        • Hôpital Laënnec
      • Paris, France, 75011
        • Clinique du Mont Louis
      • Paris, France, 75014
        • L'Institut Mutualiste Montsouris Jourdan
      • Paris, France, Cedex 20
        • Hopital De La Croix
      • Paris, France, CEDEX
        • Clinique Bizet
      • Paris Cedex, France, 75015
        • Hopital Boucicaut
      • Pessac, France, 33604
        • Hôpital Haut Lévêque
      • Pontoise, France, 95301
        • Clinique Ste-Marie
      • Quincy Sous Senart, France, 91480
        • Hopital Claude Gallien
      • Reims, France, F-51100
        • Polyclinique de Courlancy
      • Saint Jean, France, 31240
        • Oncologie Médicale
      • Sarcelles, France, 95250
        • Centre du Rouget
      • Senlis, France, 60300
        • C.H. Senlis
      • Toulon - Cedex, France, 83056
        • Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Tours, France, 37000
        • Polyclinique Flemming
      • Vannes, France, 56001
        • Centre Saint-Yves
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Luxembourg
      • Esch-sur-Alzette, Luxembourg, L-4005
        • Hopital de la Ville D'Esch-sur-Alzette

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 or biliary duct adenocarcinoma Metastatic or locally advanced No cerebral metastasis Surgically unresectable

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: More than 12 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.5 times normal No uncontrolled or persistent hypercalcemia Cardiovascular: No severe cardiac failure Pulmonary: No severe respiratory failure Other: No other malignant tumor considered incurable or untreatable No uncontrolled pain No psychological, familial, social, or geographical reasons that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids except as antiemetic Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

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

Collaborators and Investigators

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

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Study Chair: Christophe Louvet, MD, PhD, Hôpital 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.

General Publications

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

January 1, 1999

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

May 19, 2004

First Posted (Estimate)

May 20, 2004

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068440
  • FRE-GERCOR-FOLFUGEM2-D99-3
  • EU-20024

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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