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

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00010088

Collaborator

(none)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Extrahepatic Bile Duct Cancer Pancreatic Cancer	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Clinique De Rochebelle	Ales	France	F-30100
2	Centre Hospitalier Victor Dupouy	Argenteuil	France	95107
3	Centre D'Oncologie Du Pays-Basqu	Bayonne	France	F-64100
4	C.H.G. Beauvais	Beauvais	France	60021
5	Institut Bergonie	Bordeaux	France	33076
6	CMC Bligny	Briis Sous Forges	France	91640
7	Clinique Saint-Jean	Cagne-sur-Mer	France	06800
8	Hopital Fontenoy	Chartres	France	28018
9	Hopital Beaujon	Clichy	France	92118
10	Hopital Drevon	Dijon	France	21000
11	Centre D'Oncologie Dunkerquois	Dunkerque	France	59240
12	Polyclinique De La Foret	Fontaineblea	France	7300
13	CHR de Grenoble - La Tronche	Grenoble	France	38043
14	Centre De Charlebourg	La Garenne Colombes	France	92250
15	Clinique Du Cap D'OR	LA Seyne Sur Me	France	83500
16	Hopital Andre Mignot	Le Chesnay	France	78157
17	Hopital de la Croix Rousse	Lyon	France	69317
18	Assistance Publique Hopitaux de Marseille Hopitaux Sud	Marseille	France	13274
19	Hopital Notre-Dame de Bon Secours	Metz	France	55038
20	Hopital Clinique Claude Bernard	Metz	France	57070
21	Intercommunal Hospital	Montfermeil	France	93370
22	Centre Hospitalier De Moulins Yzeure	Moulins	France	03006 Cedex
23	Centre Hospitalier de Mulhouse	Mulhouse	France	68051
24	CHR Hotel Dieu	Nantes	France	44093
25	American Hospital of Paris	Neuilly Sur Seine	France	F-92202
26	CHR D'Orleans - Hopital de la Source	Orleans	France	45067
27	Hopital Boucicaut	Paris Cedex	France	75015
28	Hopital Laennec	Paris	France	75007
29	Clinique Du Mont Louis	Paris	France	75011
30	Hopital Rothschild	Paris	France	75012
31	Hopital Saint Joseph	Paris	France	75014
32	L'Institut Mutualiste Montsouris Jourdan	Paris	France	75014
33	Hopital Saint-Louis	Paris	France	75475
34	Hopital Saint Antoine	Paris	France	75571
35	Hopital Tenon	Paris	France	75970
36	Hopital De La Croix	Paris	France	Cedex 20
37	Clinique Bizet	Paris	France	CEDEX
38	Hopital Haut Leveque	Pessac	France	33604
39	Clinique Ste-Marie	Pontoise	France	95301
40	Hopital Claude Gallien	Quincy Sous Senart	France	91480
41	Polyclinique De Courlancy	Reims	France	F-51100
42	Oncologie Medicale	Saint Jean	France	31240
43	Centre du Rouget	Sarcelles	France	95250
44	C.H. Senlis	Senlis	France	60300
45	Centre Hospitalier Intercommunal Toulon - La Seyne/Mer	Toulon - Cedex	France	83056
46	Clinique Pasteur	Toulouse	France	31076
47	Polyclinique Flemming	Tours	France	37000
48	Centre Saint-Yves	Vannes	France	56001
49	Institut Gustave Roussy	Villejuif	France	F-94805
50	Hopital de la Ville D'Esch-sur-Alzette	Esch-sur-Alzette	Luxembourg	L-4005