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

Primary Purpose

Extrahepatic Bile Duct Cancer, Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fluorouracil
gemcitabine hydrochloride
leucovorin calcium
conventional surgery
radiation therapy
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique De Rochebelle
  • Centre Hospitalier Victor Dupouy
  • Centre D'Oncologie Du Pays-Basqu
  • C.H.G. Beauvais
  • Institut Bergonie
  • CMC Bligny
  • Clinique Saint-Jean
  • Hopital Fontenoy
  • Hopital Beaujon
  • Hopital Drevon
  • Centre D'Oncologie Dunkerquois
  • Polyclinique De La Foret
  • CHR de Grenoble - La Tronche
  • Centre De Charlebourg
  • Clinique Du Cap D'OR
  • Hopital Andre Mignot
  • Hopital de la Croix Rousse
  • Assistance Publique Hopitaux de Marseille Hopitaux Sud
  • Hopital Notre-Dame de Bon Secours
  • Hopital Clinique Claude Bernard
  • Intercommunal Hospital
  • Centre Hospitalier De Moulins Yzeure
  • Centre Hospitalier de Mulhouse
  • CHR Hotel Dieu
  • American Hospital of Paris
  • CHR D'Orleans - Hopital de la Source
  • Hopital Boucicaut
  • Hopital Laennec
  • Clinique Du Mont Louis
  • Hopital Rothschild
  • Hopital Saint Joseph
  • L'Institut Mutualiste Montsouris Jourdan
  • Hopital Saint-Louis
  • Hopital Saint Antoine
  • Hopital Tenon
  • Hopital De La Croix
  • Clinique Bizet
  • Hopital Haut Leveque
  • Clinique Ste-Marie
  • Hopital Claude Gallien
  • Polyclinique De Courlancy
  • Oncologie Medicale
  • Centre du Rouget
  • C.H. Senlis
  • Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
  • Clinique Pasteur
  • Polyclinique Flemming
  • Centre Saint-Yves
  • Institut Gustave Roussy
  • Hopital de la Ville D'Esch-sur-Alzette

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
February 6, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00010088
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Pancreatic Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Louvet, MD, PhD
Organizational Affiliation
Hopital Saint Antoine
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique De Rochebelle
City
Ales
ZIP/Postal Code
F-30100
Country
France
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Centre D'Oncologie Du Pays-Basqu
City
Bayonne
ZIP/Postal Code
F-64100
Country
France
Facility Name
C.H.G. Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CMC Bligny
City
Briis Sous Forges
ZIP/Postal Code
91640
Country
France
Facility Name
Clinique Saint-Jean
City
Cagne-sur-Mer
ZIP/Postal Code
06800
Country
France
Facility Name
Hopital Fontenoy
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre D'Oncologie Dunkerquois
City
Dunkerque
ZIP/Postal Code
59240
Country
France
Facility Name
Polyclinique De La Foret
City
Fontaineblea
ZIP/Postal Code
7300
Country
France
Facility Name
CHR de Grenoble - La Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre De Charlebourg
City
La Garenne Colombes
ZIP/Postal Code
92250
Country
France
Facility Name
Clinique Du Cap D'OR
City
LA Seyne Sur Me
ZIP/Postal Code
83500
Country
France
Facility Name
Hopital Andre Mignot
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Assistance Publique Hopitaux de Marseille Hopitaux Sud
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
55038
Country
France
Facility Name
Hopital Clinique Claude Bernard
City
Metz
ZIP/Postal Code
57070
Country
France
Facility Name
Intercommunal Hospital
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Centre Hospitalier De Moulins Yzeure
City
Moulins
ZIP/Postal Code
03006 Cedex
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
CHR Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
American Hospital of Paris
City
Neuilly Sur Seine
ZIP/Postal Code
F-92202
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Boucicaut
City
Paris Cedex
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Laennec
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Clinique Du Mont Louis
City
Paris
ZIP/Postal Code
75011
Country
France
Facility Name
Hopital Rothschild
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
L'Institut Mutualiste Montsouris Jourdan
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital De La Croix
City
Paris
ZIP/Postal Code
Cedex 20
Country
France
Facility Name
Clinique Bizet
City
Paris
ZIP/Postal Code
CEDEX
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Clinique Ste-Marie
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
Hopital Claude Gallien
City
Quincy Sous Senart
ZIP/Postal Code
91480
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Oncologie Medicale
City
Saint Jean
ZIP/Postal Code
31240
Country
France
Facility Name
Centre du Rouget
City
Sarcelles
ZIP/Postal Code
95250
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60300
Country
France
Facility Name
Centre Hospitalier Intercommunal Toulon - La Seyne/Mer
City
Toulon - Cedex
ZIP/Postal Code
83056
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Polyclinique Flemming
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Centre Saint-Yves
City
Vannes
ZIP/Postal Code
56001
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Hopital de la Ville D'Esch-sur-Alzette
City
Esch-sur-Alzette
ZIP/Postal Code
L-4005
Country
Luxembourg

12. IPD Sharing Statement

Citations:
PubMed Identifier
17235048
Citation
Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.
Results Reference
background
PubMed Identifier
15646530
Citation
Andre T, Noirclerc M, Hammel P, Meckenstock R, Landi B, Cattan S, Selle F, Codoul JF, Guerrier-Parmentier B, Mokhtar R, Louvet C; GERCOR. Phase II study of leucovorin, 5-fluorouracil and gemcitabine for locally advanced and metastatic pancreatic cancer (FOLFUGEM 2). Gastroenterol Clin Biol. 2004 Aug-Sep;28(8-9):645-50. doi: 10.1016/s0399-8320(04)95042-7.
Results Reference
result

Learn more about this trial

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

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