Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
Recruitment status was Active, not recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
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 | |
| 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 Clinique Claude Bernard | |
| Metz, France, 57070 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 55038 | |
| 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 | |
| Clinique Du Mont Louis | |
| Paris, France, 75011 | |
| Clinique Bizet | |
| Paris, France, CEDEX | |
| Hopital De La Croix | |
| Paris, France, Cedex 20 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Rothschild | |
| Paris, France, 75012 | |
| Hopital Laennec | |
| Paris, France, 75007 | |
| Hopital Saint Joseph | |
| Paris, France, 75014 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| L'Institut Mutualiste Montsouris Jourdan | |
| Paris, France, 75014 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Hopital Boucicaut | |
| Paris Cedex, France, 75015 | |
| 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 | |
| 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
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00010088 History of Changes |
| Other Study ID Numbers: | CDR0000068440, FRE-GERCOR-FOLFUGEM2-D99-3, EU-20024 |
| Study First Received: | February 2, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
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:
|
Adenocarcinoma Pancreatic Neoplasms Bile Duct Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms 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 Fluorouracil Gemcitabine Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex |
ClinicalTrials.gov processed this record on May 16, 2013