Clinical trial NCT00010088: 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
Overall status: UNKNOWN
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-05-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

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