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

Pancreatic Cancer Clinical Trial

Official title:

Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00010088
• Other study ID #: CDR0000068440
• Secondary ID: FRE-GERCOR-FOLFU
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: February 6, 2009
• Start date: January 1999

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Extrahepatic Bile Duct Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• fluorouracil

• gemcitabine hydrochloride

• leucovorin calcium

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Clinique De Rochebelle	Ales
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	Centre D'Oncologie Du Pays-Basqu	Bayonne
France	C.H.G. Beauvais	Beauvais
France	Institut Bergonie	Bordeaux
France	CMC Bligny	Briis Sous Forges
France	Clinique Saint-Jean	Cagne-sur-Mer
France	Hopital Fontenoy	Chartres
France	Hopital Beaujon	Clichy
France	Hopital Drevon	Dijon
France	Centre D'Oncologie Dunkerquois	Dunkerque
France	Polyclinique De La Foret	Fontaineblea
France	CHR de Grenoble - La Tronche	Grenoble
France	Centre De Charlebourg	La Garenne Colombes
France	Clinique Du Cap D'OR	LA Seyne Sur Me
France	Hopital Andre Mignot	Le Chesnay
France	Hopital de la Croix Rousse	Lyon
France	Assistance Publique Hopitaux de Marseille Hopitaux Sud	Marseille
France	Hopital Clinique Claude Bernard	Metz
France	Hopital Notre-Dame de Bon Secours	Metz
France	Intercommunal Hospital	Montfermeil
France	Centre Hospitalier De Moulins Yzeure	Moulins
France	Centre Hospitalier de Mulhouse	Mulhouse
France	CHR Hotel Dieu	Nantes
France	American Hospital of Paris	Neuilly Sur Seine
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Clinique Bizet	Paris
France	Clinique Du Mont Louis	Paris
France	Hopital De La Croix	Paris
France	Hopital Laennec	Paris
France	Hopital Rothschild	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Saint Joseph	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	L'Institut Mutualiste Montsouris Jourdan	Paris
France	Hopital Boucicaut	Paris Cedex
France	Hopital Haut Leveque	Pessac
France	Clinique Ste-Marie	Pontoise
France	Hopital Claude Gallien	Quincy Sous Senart
France	Polyclinique De Courlancy	Reims
France	Oncologie Medicale	Saint Jean
France	Centre du Rouget	Sarcelles
France	C.H. Senlis	Senlis
France	Centre Hospitalier Intercommunal Toulon - La Seyne/Mer	Toulon - Cedex
France	Clinique Pasteur	Toulouse
France	Polyclinique Flemming	Tours
France	Centre Saint-Yves	Vannes
France	Institut Gustave Roussy	Villejuif
Luxembourg	Hopital de la Ville D'Esch-sur-Alzette	Esch-sur-Alzette

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Countries where clinical trial is conducted

France,  Luxembourg, 

References & Publications (2)

André 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 (F — View Citation

Huguet F, André 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. — View Citation