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	Treatment or Intervention	Phase
adenocarcinoma of the extrahepatic bile duct stage II pancreatic cancer stage IVA pancreatic cancer stage III pancreatic cancer stage IVB pancreatic cancer unresectable extrahepatic bile duct cancer adenocarcinoma of the pancreas	Drug: fluorouracil  Drug: gemcitabine  Drug: leucovorin calcium	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed pancreatic or biliary duct adenocarcinoma
• Metastatic or locally advanced; No cerebral metastasis
• Surgically unresectable

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Endocrine therapy: No concurrent corticosteroids except as antiemetic
• Radiotherapy: No prior radiotherapy
• Surgery: See Disease Characteristics

--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

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

Study chairs or principal investigators

Christophe Louvet,  Study Chair,  GERCOR   

Study ID Numbers:  CDR0000068440; FRE-GERCOR-FOLFUGEM2-D99-3; EU-20024
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010088
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08