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Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct



Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

For Condition: stage 2 pancreatic cancer,stage 4B pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer,unresectable extrahepatic bile duct cancer,adenocarcinoma of the extrahepatic bile duct,stage 4A pancreatic cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: 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 .
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ChristopheLouvet,  Study Chair,  GERCOR

Polyclinique Flemming
Tours,  ,  37000
France
 

Hopital Claude Gallien
Quincy-sous-Senart,  ,  91480
France
 

Institut Bergonie
Bordeaux,  ,  33076
France
 

CMC Bligny
Briis-sous-Forges,  ,  91640
France
 

Hopital Haut Leveque
Pessac,  ,  33604
France
 

Centre du Rouget
Sarcelles,  ,  95250
France
 

Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille,  ,  13274
France
 

Hopital Saint Antoine
Paris,  ,  75571
France
 

Clinique Saint-Jean
Cagne-sur-Mer,  ,  06800
France
 

Hopital Saint Joseph
Paris,  ,  75014
France
 

Institut Gustave Roussy
Villejuif,  ,  F-94805
France
 

Hopital Drevon
Dijon,  ,  21000
France
 

Hopital Clinique Claude Bernard
Metz,  ,  57070
France
 

American Hospital of Paris
Neuilly-sur-Seine,  ,  F-92202
France
 

Polyclinique De La Foret
Fontaineblea,  ,  7300
France
 

C.H. Senlis
Senlis,  ,  60300
France
 

Hopital De La Croix
Paris,  ,  Cedex 20
France
 

Centre Hospitalier de Mulhouse
Mulhouse,  ,  68051
France
 

Centre Hospitalier De Moulins Yzeure
Moulins,  ,  03006 Cedex
France
 

Clinique Bizet
Paris,  ,  CEDEX
France
 

Intercommunal Hospital
Montfermeil,  ,  93370
France
 

Centre D'Oncologie Du Pays-Basqu
Bayonne,  ,  F-64100
France
 

Hopital Andre Mignot
Le Chesnay,  ,  78157
France
 

CHR Hotel Dieu
Nantes,  ,  44093
France
 

Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
Toulon - Cedex,  ,  83056
France
 

Clinique Ste-Marie
Pontoise,  ,  95301
France
 

Clinique Du Cap D'OR
LA Seyne Sur Me,  ,  83500
France
 

Hopital Tenon
Paris,  ,  75970
France
 

Clinique Du Mont Louis
Paris,  ,  75011
France
 

Centre De Charlebourg
La Garenne-Colombes,  ,  92250
France
 

Hopital Fontenoy
Chartres,  ,  28018
France
 

CHR D'Orleans - Hopital de la Source
Orleans,  ,  45067
France
 

Centre Saint-Yves
Vannes,  ,  56001
France
 

Hopital Beaujon
Clichy,  ,  92118
France
 

Hopital Saint-Louis
Paris,  ,  75475
France
 

Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette,  ,  L-4005
Luxembourg
 

L'Institut Mutualiste Montsouris Jourdan
Paris,  ,  75014
France
 

Polyclinique De Courlancy
Reims,  ,  F-51100
France
 

Centre Hospitalier Victor Dupouy
Argenteuil,  ,  95107
France
 

Clinique Pasteur
Toulouse,  ,  31076
France
 

Clinique De Rochebelle
Ales,  ,  F-30100
France
 

Hopital Notre-Dame de Bon Secours
Metz,  ,  55038
France
 

CHR de Grenoble - La Tronche
Grenoble,  ,  38043
France
 

Hopital Laennec
Paris,  ,  75007
France
 

Hopital de la Croix Rousse
Lyon,  ,  69317
France
 

C.H.G. Beauvais
Beauvais,  ,  60021
France
 

Centre D'Oncologie Dunkerquois
Dunkerque,  ,  59240
France
 

Hopital Boucicaut
Paris cedex,  ,  75015
France
 

Oncologie Medicale
Saint-Jean,  ,  31240
France
 

Hopital Rothschild
Paris,  ,  75012
France
 


Additional Information:
Study ID Numbers:
  CDR0000068440;  EU-20024,FRE-GERCOR-FOLFUGEM2-D99-3
Study Start Date: January 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010088

Other Adenocarcinoma Of The Extrahepatic Bile Duct Studies:
1. Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed

2. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery

3. Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer

4. Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer

5. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

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