- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010088
Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
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
Conditions
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
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ales, France, F-30100
- Clinique De Rochebelle
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Argenteuil, France, 95107
- Centre Hospitalier Victor Dupouy
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Bayonne, France, F-64100
- Centre D'Oncologie Du Pays-Basqu
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Beauvais, France, 60021
- C.H.G. Beauvais
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Bordeaux, France, 33076
- Institut Bergonié
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Briis Sous Forges, France, 91640
- CMC Bligny
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Cagne-sur-Mer, France, 06800
- Clinique Saint-Jean
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Chartres, France, 28018
- Hopital Fontenoy
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Clichy, France, 92118
- Hopital Beaujon
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Dijon, France, 21000
- Hopital Drevon
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Dunkerque, France, 59240
- Centre D'Oncologie Dunkerquois
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Fontaineblea, France, 7300
- Polyclinique De La Foret
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Grenoble, France, 38043
- Chr De Grenoble - La Tronche
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LA Seyne Sur Me, France, 83500
- Clinique du Cap d'Or
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La Garenne Colombes, France, 92250
- Centre De Charlebourg
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Le Chesnay, France, 78157
- Hôpital André Mignot
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Lyon, France, 69317
- Hôpital de la Croix Rousse
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Marseille, France, 13274
- Assistance Publique Hopitaux de Marseille Hopitaux Sud
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Metz, France, 55038
- Hopital Notre-Dame de Bon Secours
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Metz, France, 57070
- Hopital Clinique Claude Bernard
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Montfermeil, France, 93370
- Intercommunal Hospital
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Moulins, France, 03006 Cedex
- Centre Hospitalier De Moulins Yzeure
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Mulhouse, France, 68051
- Centre Hospitalier de Mulhouse
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Nantes, France, 44093
- CHR Hotel Dieu
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Neuilly Sur Seine, France, F-92202
- American Hospital of Paris
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Orleans, France, 45067
- CHR D'Orleans - Hopital de la Source
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Paris, France, 75970
- Hôpital Tenon
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Paris, France, 75014
- Hôpital Saint Joseph
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Paris, France, 75571
- Hopital Saint Antoine
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Paris, France, 75475
- Hopital Saint-Louis
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Paris, France, 75012
- Hôpital Rothschild
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Paris, France, 75007
- Hôpital Laënnec
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Paris, France, 75011
- Clinique du Mont Louis
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Paris, France, 75014
- L'Institut Mutualiste Montsouris Jourdan
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Paris, France, Cedex 20
- Hopital De La Croix
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Paris, France, CEDEX
- Clinique Bizet
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Paris Cedex, France, 75015
- Hopital Boucicaut
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Pessac, France, 33604
- Hôpital Haut Lévêque
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Pontoise, France, 95301
- Clinique Ste-Marie
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Quincy Sous Senart, France, 91480
- Hopital Claude Gallien
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Reims, France, F-51100
- Polyclinique de Courlancy
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Saint Jean, France, 31240
- Oncologie Médicale
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Sarcelles, France, 95250
- Centre du Rouget
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Senlis, France, 60300
- C.H. Senlis
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Toulon - Cedex, France, 83056
- Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
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Toulouse, France, 31076
- Clinique PASTEUR
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Tours, France, 37000
- Polyclinique Flemming
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Vannes, France, 56001
- Centre Saint-Yves
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Villejuif, France, F-94805
- Institut Gustave Roussy
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Esch-sur-Alzette, Luxembourg, L-4005
- Hopital de la Ville D'Esch-sur-Alzette
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Christophe Louvet, MD, PhD, Hopital Saint Antoine
Publications and helpful links
General Publications
- Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.
- Andre T, Noirclerc M, Hammel P, Meckenstock R, Landi B, Cattan S, Selle F, Codoul JF, Guerrier-Parmentier B, Mokhtar R, Louvet C; GERCOR. Phase II study of leucovorin, 5-fluorouracil and gemcitabine for locally advanced and metastatic pancreatic cancer (FOLFUGEM 2). Gastroenterol Clin Biol. 2004 Aug-Sep;28(8-9):645-50. doi: 10.1016/s0399-8320(04)95042-7.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Biliary Tract Diseases
- Pancreatic Diseases
- Bile Duct Diseases
- Biliary Tract Neoplasms
- Pancreatic Neoplasms
- Cholangiocarcinoma
- Bile Duct Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antidotes
- Vitamin B Complex
- Gemcitabine
- Fluorouracil
- Leucovorin
- Calcium
- Levoleucovorin
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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