Spots Global Cancer Trial Database for Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
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Trial Identification
Brief Title: Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
Official Title: Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas
Study ID: NCT00010088
Study Description
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clinique De Rochebelle, Ales, , France
Centre Hospitalier Victor Dupouy, Argenteuil, , France
Centre D'Oncologie Du Pays-Basqu, Bayonne, , France
C.H.G. Beauvais, Beauvais, , France
Institut Bergonie, Bordeaux, , France
CMC Bligny, Briis Sous Forges, , France
Clinique Saint-Jean, Cagne-sur-Mer, , France
Hopital Fontenoy, Chartres, , France
Hopital Beaujon, Clichy, , France
Hopital Drevon, Dijon, , France
Centre D'Oncologie Dunkerquois, Dunkerque, , France
Polyclinique De La Foret, Fontaineblea, , France
CHR de Grenoble - La Tronche, Grenoble, , France
Centre De Charlebourg, La Garenne Colombes, , France
Clinique Du Cap D'OR, LA Seyne Sur Me, , France
Hopital Andre Mignot, Le Chesnay, , France
Hopital de la Croix Rousse, Lyon, , France
Assistance Publique Hopitaux de Marseille Hopitaux Sud, Marseille, , France
Hopital Notre-Dame de Bon Secours, Metz, , France
Hopital Clinique Claude Bernard, Metz, , France
Intercommunal Hospital, Montfermeil, , France
Centre Hospitalier De Moulins Yzeure, Moulins, , France
Centre Hospitalier de Mulhouse, Mulhouse, , France
CHR Hotel Dieu, Nantes, , France
American Hospital of Paris, Neuilly Sur Seine, , France
CHR D'Orleans - Hopital de la Source, Orleans, , France
Hopital Boucicaut, Paris Cedex, , France
Hopital Laennec, Paris, , France
Clinique Du Mont Louis, Paris, , France
Hopital Rothschild, Paris, , France
Hopital Saint Joseph, Paris, , France
L'Institut Mutualiste Montsouris Jourdan, Paris, , France
Hopital Saint-Louis, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Tenon, Paris, , France
Hopital De La Croix, Paris, , France
Clinique Bizet, Paris, , France
Hopital Haut Leveque, Pessac, , France
Clinique Ste-Marie, Pontoise, , France
Hopital Claude Gallien, Quincy Sous Senart, , France
Polyclinique De Courlancy, Reims, , France
Oncologie Medicale, Saint Jean, , France
Centre du Rouget, Sarcelles, , France
C.H. Senlis, Senlis, , France
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer, Toulon - Cedex, , France
Clinique Pasteur, Toulouse, , France
Polyclinique Flemming, Tours, , France
Centre Saint-Yves, Vannes, , France
Institut Gustave Roussy, Villejuif, , France
Hopital de la Ville D'Esch-sur-Alzette, Esch-sur-Alzette, , Luxembourg
Contact Details
Name: Christophe Louvet, MD, PhD
Affiliation: Hopital Saint Antoine
Role: STUDY_CHAIR
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