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

NCT00010088 | Unknown Phase 2

• 3 other identifiers: CDR0000068440FRE-GERCOR-FOLFUGEM2-D99-3EU-20024
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 50

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.

Conditions

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

Interventions

fluorouracil DRUG

gemcitabine hydrochloride DRUG

leucovorin calcium DRUG

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (50)

Clinique De Rochebelle

Alès, F-30100, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Centre D'Oncologie Du Pays-Basqu

Bayonne, F-64100, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CMC Bligny

Briis-sous-Forges, 91640, France

Location

Clinique Saint-Jean

Cagne-sur-Mer, 06800, France

Location

Hopital Fontenoy

Chartres, 28018, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Centre D'Oncologie Dunkerquois

Dunkirk, 59240, France

Location

Polyclinique De La Foret

Fontaineblea, 7300, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Centre De Charlebourg

La Garenne-Colombes, 92250, France

Location

Clinique Du Cap D'OR

LA Seyne Sur Me, 83500, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Assistance Publique Hopitaux de Marseille Hopitaux Sud

Marseille, 13274, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 55038, France

Location

Hopital Clinique Claude Bernard

Metz, 57070, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

Centre Hospitalier De Moulins Yzeure

Moulins, 03006 Cedex, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Hopital Laennec

Paris, 75007, France

Location

Clinique Du Mont Louis

Paris, 75011, France

Location

Hopital Rothschild

Paris, 75012, France

Location

Hopital Saint Joseph

Paris, 75014, France

Location

L'Institut Mutualiste Montsouris Jourdan

Paris, 75014, France

Location

Hopital Boucicaut

Paris, 75015, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital De La Croix

Paris, Cedex 20, France

Location

Clinique Bizet

Paris, CEDEX, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Clinique Ste-Marie

Pontoise, 95301, France

Location

Hopital Claude Gallien

Quincy-sous-Sénart, 91480, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Oncologie Medicale

Saint-Jean, 31240, France

Location

Centre du Rouget

Sarcelles, 95250, France

Location

C.H. Senlis

Senlis, 60300, France

Location

Centre Hospitalier Intercommunal Toulon - La Seyne/Mer

Toulon, 83056, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Polyclinique Flemming

Tours, 37000, France

Location

Centre Saint-Yves

Vannes, 56001, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Hopital de la Ville D'Esch-sur-Alzette

Esch-sur-Alzette, L-4005, Luxembourg

Location

Related Publications (2)

• 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.

  PMID: 17235048 BACKGROUND

• 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.

  PMID: 15646530 RESULT

MeSH Terms

Conditions

Bile Duct Neoplasms; Pancreatic Neoplasms

Interventions

Fluorouracil; Gemcitabine; Leucovorin; Radiotherapy

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Therapeutics

Study Officials

• Christophe Louvet, MD, PhD

  Hopital Saint Antoine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: May 20, 2004
• Study Start: January 1, 1999
• Last Updated: February 9, 2009

Record last verified: 2007-04

Locations

FR (49); LU (1)