Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery - Full Text View

Sponsored by:	Fondation Francaise de Cancerologie Digestive
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00304135

Purpose

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer.

PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.

Condition	Intervention	Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer	Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: oxaliplatin	Phase II Phase III

MedlinePlus related topics: Cancer Gallbladder Cancer Liver Cancer

Drug Information available for: Cisplatin Gemcitabine hydrochloride Gemcitabine Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression rate at 3 months [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Quality of life [ Designated as safety issue: No ]
Biliary complication rate [ Designated as safety issue: No ]
Duration of hospitalization [ Designated as safety issue: No ]

Estimated Enrollment:	170
Study Start Date:	October 2005
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare the 3-month progression rate in patients with unresectable, nonmetastatic cancer of the biliary tract treated with fluorouracil, cisplatin, and radiotherapy vs gemcitabine hydrochloride and oxaliplatin. (phase II)
Compare the overall survival of patients treated with these regimens. (phase III)

Secondary

Compare toxicities of these regimens in these patients. (phase II)
Compare the quality of life at initial drainage (phase II) and overall (phase III) of patients treated with these regimens.
Compare the biliary complication rate in patients treated with these regimens.
Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease location (gallbladder vs intrahepatic biliary duct vs extrahepatic biliary duct). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo radiotherapy once daily, 5 days a week on days 1-33. Patients also receive fluorouracil IV continuously over 5 days once a week in weeks 1-5 and cisplatin IV over 15 minutes on days 1-4 and 29-32 (or days 1 or 2 and 29 or 30) in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months thereafter.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of cancer of the biliary tract by 1 of the following methods:
- Histologic confirmation
- Stenosis of the biliary tract by MRI, CT scan, or ECHO
Unresectable disease
Amenable to radiotherapy
No visceral metastases by imaging
- Hepatic adenopathies that can be included in a radiation field allowed
No known ampulla of Vater or pancreatic cancer involving the biliary tract

PATIENT CHARACTERISTICS:

WHO performance status 0-2
Creatinine < 1.5 mg/dL
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 75,000/mm^3
Prothrombin time > 70%
Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed)
No unstable angina
No symptomatic cardiac insufficiency
No other comorbidity that would preclude study therapy
No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
No prior hydatid cyst or alveolar echinococciasis
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

No recent biliary surgery
No hepatic intra-arterial chemotherapy
No prior anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304135

Locations

France
C. H. Du Mans	Recruiting
Le Mans, France, 72037
Contact: Marie-Aude Coulon 33-2-4343-4343
Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Recruiting
Dijon, France, 21079
Contact: Bruno Chauffert 33-3-8073-7506 bchauffert@dijon.fnclcc.fr
Centre Eugene Marquis	Recruiting
Rennes, France, 35062
Contact: Eveline Boucher, MD 33-2-9925-3180
Centre Hospitalier de Dax	Recruiting
Dax, France, 40107
Contact: Laure Gautier-Felizot 33-6-8591-9735
Centre Hospitalier de Semur en Auxois	Recruiting
Semur en Auxois, France, 21140
Contact: Patenotte 33-3-8089-6464
Centre Hospitalier de Tarbes	Recruiting
Tarbes, France, 65013
Contact: Glibert 33-5-6251-5151
Centre Hospitalier Departemental	Recruiting
La Roche Sur Yon, France, F-85025
Contact: Roger Faroux 33-2-5144-6168
Centre Hospitalier General de Mont de Marsan	Recruiting
Mont-de-Marsan, France, 40000
Contact: Patrick Texereau, MD 33-5-5805-1164
Centre Hospitalier General	Recruiting
Belfort, France, 90000
Contact: Serge Fratte, MD 33-384-574-095 sfratte@ch-montbeliard-belfort.rss.fr
Centre Hospitalier Lyon Sud	Recruiting
Pierre Benite, France, 69495
Contact: Francoise Mornex, MD, PhD 33-478-864-253 francoise.mornex@chu-lyon.fr
Hopital Universitaire Hautepierre	Recruiting
Strasbourg, France, 67098
Contact: Palascak 33-388-127-682
CHR D'Orleans - Hopital de la Source	Recruiting
Orleans, France, 45100
Contact: Jean-Paul Lagasse 33-02-3651-4704
CHU de la Timone	Recruiting
Marseille, France, 13385
Contact: Jean-Francois Seitz, MD 33-4-9138-6023
CHU Pitie-Salpetriere	Recruiting
Paris, France, 75651
Contact: Julien Taieb, MD 33-1-4216-1023
Hopital Bichat - Claude Bernard	Recruiting
Paris, France, 75018
Contact: Thomas Aparicio 33-1-4025-7200 thomas.aparicio@bch.ap-hop-paris.fr
Hopital Charles Nicolle	Recruiting
Rouen, France, 76031
Contact: Pierre Michel 33-2-3288-8260
Hopital Du Bocage	Recruiting
Dijon, France, 21034
Contact: Laurent Bedenne, MD 33-3-8029-3750 lbedenne@u-bourgogne.fr
Hopital Louis Pasteur	Recruiting
Colmar, France, 68024
Contact: Bernard Denis 33-3-8912-4097
Hopital Sebastopol, C.H.U. de Reims	Recruiting
Reims, France, 51092
Contact: Stephanie Lagarde 33-326-784-410
Centre Hospitalier Pierre Oudot	Recruiting
Bourgoin-Jallieu, France, 38300
Contact: Noel Stremsdoerfer, MD 33-4-7427-3011

Sponsors and Collaborators

Fondation Francaise de Cancerologie Digestive

Investigators

Principal Investigator:

Bruno Chauffert

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000470411, FFCD-9902, SANOFI-FFCD-9902, LILLY-FFCD-9902, FFCD-FNCLCC-SFRO-9902
Study First Received:	March 15, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00304135
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

localized unresectable adult primary liver cancer
unresectable extrahepatic bile duct cancer
unresectable gallbladder cancer

Study placed in the following topic categories:

Bile duct cancer, extrahepatic
Gallbladder Diseases
Liver Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
Biliary tract cancer
Liver neoplasms
Gall bladder cancer
Liver Neoplasms
Oxaliplatin

Digestive System Diseases
Cisplatin
Bile Duct Diseases
Fluorouracil
Biliary Tract Diseases
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Gemcitabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009