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

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: NCT00010088
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2004
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Extrahepatic Bile Duct Cancer Pancreatic Cancer Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy Phase 2

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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas
Study Start Date : January 1999

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00010088

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

Publications of Results:
Other Publications: Identifier: NCT00010088     History of Changes
Other Study ID Numbers: CDR0000068440
First Posted: May 20, 2004    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: April 2007

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
unresectable extrahepatic bile duct cancer
adenocarcinoma of the extrahepatic bile duct
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Neoplasms
Bile Duct Diseases
Biliary Tract 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