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| Sponsor: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00010088 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Extrahepatic Bile Duct Cancer Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | 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 |
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Hide Study Locations| France | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| Assistance Publique Hopitaux de Marseille Hopitaux Sud | |
| Marseille, France, 13274 | |
| C.H. Senlis | |
| Senlis, France, 60300 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| Centre D'Oncologie Du Pays-Basqu | |
| Bayonne, France, F-64100 | |
| Centre D'Oncologie Dunkerquois | |
| Dunkerque, France, 59240 | |
| Centre De Charlebourg | |
| La Garenne Colombes, France, 92250 | |
| Centre du Rouget | |
| Sarcelles, France, 95250 | |
| Centre Hospitalier De Moulins Yzeure | |
| Moulins, France, 03006 Cedex | |
| Centre Hospitalier de Mulhouse | |
| Mulhouse, France, 68051 | |
| Centre Hospitalier Intercommunal Toulon - La Seyne/Mer | |
| Toulon - Cedex, France, 83056 | |
| Centre Hospitalier Victor Dupouy | |
| Argenteuil, France, 95107 | |
| Hopital Andre Mignot | |
| Le Chesnay, France, 78157 | |
| CHR D'Orleans - Hopital de la Source | |
| Orleans, France, 45067 | |
| CHR de Grenoble - La Tronche | |
| Grenoble, France, 38043 | |
| CHR Hotel Dieu | |
| Nantes, France, 44093 | |
| Clinique Bizet | |
| Paris, France, CEDEX | |
| Clinique De Rochebelle | |
| Ales, France, F-30100 | |
| Clinique Du Cap D'OR | |
| LA Seyne Sur Me, France, 83500 | |
| Clinique Du Mont Louis | |
| Paris, France, 75011 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| Clinique Saint-Jean | |
| Cagne-sur-Mer, France, 06800 | |
| Clinique Ste-Marie | |
| Pontoise, France, 95301 | |
| CMC Bligny | |
| Briis Sous Forges, France, 91640 | |
| Centre Saint-Yves | |
| Vannes, France, 56001 | |
| Hopital Beaujon | |
| Clichy, France, 92118 | |
| Hopital Boucicaut | |
| Paris Cedex, France, 75015 | |
| Hopital Claude Gallien | |
| Quincy Sous Senart, France, 91480 | |
| Hopital Clinique Claude Bernard | |
| Metz, France, 57070 | |
| Hopital De La Croix | |
| Paris, France, Cedex 20 | |
| Hopital de la Croix Rousse | |
| Lyon, France, 69317 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Haut Leveque | |
| Pessac, France, 33604 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 55038 | |
| Hopital Rothschild | |
| Paris, France, 75012 | |
| Hopital Fontenoy | |
| Chartres, France, 28018 | |
| Hopital Saint Joseph | |
| Paris, France, 75014 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Intercommunal Hospital | |
| Montfermeil, France, 93370 | |
| L'Institut Mutualiste Montsouris Jourdan | |
| Paris, France, 75014 | |
| Oncologie Medicale | |
| Saint Jean, France, 31240 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Polyclinique De La Foret | |
| Fontaineblea, France, 7300 | |
| Polyclinique Flemming | |
| Tours, France, 37000 | |
| Luxembourg | |
| Hopital de la Ville D'Esch-sur-Alzette | |
| Esch-sur-Alzette, Luxembourg, L-4005 | |
| Study Chair: | Christophe Louvet, MD, PhD | Hopital Saint Antoine |
More Information
| Study ID Numbers: | CDR0000068440, FRE-GERCOR-FOLFUGEM2-D99-3, EU-20024 |
| Study First Received: | February 2, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00010088 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Leucovorin Neoplasms by Site Vitamins Biliary Tract Diseases Therapeutic Uses Micronutrients Gemcitabine |
Endocrine Gland Neoplasms Vitamin B Complex Digestive System Neoplasms Neoplasms by Histologic Type Biliary Tract Neoplasms Growth Substances Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents |
