Combination Chemotherapy in Treating Patients With Metastatic Pancreatic 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:	NCT00303758

Purpose

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium	Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Cisplatin Gemcitabine hydrochloride Gemcitabine Fluorouracil Calcium gluconate Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

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

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Quality of life [ Designated as safety issue: No ]
Percentage of patients needing second-line therapy [ Designated as safety issue: No ]
Duration of hospitalization [ Designated as safety issue: No ]

Estimated Enrollment:	202
Study Start Date:	October 2005

Detailed Description:

OBJECTIVES:

Primary

Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.

Secondary

Compare progression-free survival of patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Compare the quality of life of patients treated with these regimens.
Compare the percentage of these patients needing second-line therapy.
Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.

Quality of life is assessed at baseline and then every 2 months.

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

PROJECTED ACCRUAL: A total of 202 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:

Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla
- Metastatic disease
- Unresectable disease
Measurable disease, meeting the following criteria:
- No prior radiotherapy to the only site of measurable disease
- Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods
No brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy > 2 months
No contraindication to chemotherapy
Creatinine clearance > 60 mL/min
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Alkaline phosphatase < 5 times normal
Bilirubin ≤ 3 mg/dL
No coronary insufficiency
No symptomatic cardiac disease
Good hydration possible
No Child-Pugh class B or C cirrhosis
No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior palliative or adjuvant chemotherapy
At least 4 weeks since prior radiotherapy
No radiotherapy during or for 4 weeks after study therapy
No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303758

Locations

France
C.H. Bourg En Bresse
Bourg En Bresse, France, 01012
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Eugene Marquis
Rennes, France, 35064
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Centre Hospitalier d'Abbeville
Abbeville, France, 80101
Centre Hospitalier de Blois
Blois, France, 41016
Centre Hospitalier de Chalons-en-Champagne
Chalons-en-Champagne, France, 51000
Centre Hospitalier De Dunkerque - CHD
Dunkerque, France, 59240
Centre Hospitalier de Martigues
Martigues, France, 13698
Centre Hospitalier de Saint-Quentin
Saint-Quentin, France, 02321
Centre Hospitalier de Semur en Auxois
Semur en Auxois, France, 21140
Centre Hospitalier de Soissons
Soissons cedex, France, 02209
Centre Hospitalier de Tarbes
Tarbes, France, 65013
Centre Hospitalier Docteur Duchenne
Boulogne Sur Mer, France, 62200
Centre Hospitalier Draguignan
Draguignan, France, 83300
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, France, 40000
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
Elbeuf, France, 76503
Centre Hospitalier Pierre Oudot
Bourgoin-Jallieu, France, 38300
Centre Hospitalier Regional et Universitaire de Lille
Lille, France, 59037
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne, France, F-92104
Centre Hospitalier Universitaire d'Amiens
Caen, France, 14076
Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
Saint Martin Boulogne, France, 62280
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Nouvelle Clinique Generale
Valence, France, 26000
CHR D'Orleans - Hopital de la Source
Orleans, France, 45100
CHR Hotel Dieu
Nantes, France, 44093
CHU - Robert Debre
Reims, France, 51092
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
CHU de la Timone
Marseille, France, 13385
CHU Nord
Marseille, France, 13915
Clinique Armoricaine De Radiologie
Saint Brieuc, France, F-22015
Clinique Pasteur
Guilherand Granges, France, 07500
Clinique Ste - Marie
Pontoise, France, 95301
Hopital Beaujon
Clichy, France, 92118
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Charles Nicolle
Rouen, France, 76031
Hopital Du Bocage
Dijon, France, 21034
Hopital Duffaut
Avignon, France, 84902
Hopital Edouard Herriot
Lyon, France, 69437
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Haut Leveque
Pessac, France, 33604
Hopital Louis Pasteur
Colmar, France, 68024
Hopital Robert Boulin
Libourne, France, 33500
Hopital Saint Joseph
Marseille, France, 13008
Hopital Universitaire Hautepierre
Strasbourg, France, 67098
CHR Clermont Ferrand, Hotel dieu
Clermont-Ferrand, France, 63003

Sponsors and Collaborators

Fondation Francaise de Cancerologie Digestive

Investigators

Study Chair:	Jean-Francois Seitz, MD	CHU de la Timone
Investigator:	Jean-Louis Legoux, MD	Hopital Haut Leveque
Investigator:	P. Hammel, MD, PhD	Hopital Beaujon

More Information

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

Publications of Results:

Mitry E, Dahan L, Ychou M, et al.: LV5FU2-cisplatin followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: preliminary results of a randomized phase III trial (FFCD 0301). [Abstract] J Clin Oncol 26 (Suppl 15): A-4513, 2008.

Study ID Numbers:	CDR0000453841, FFCD-0301, EU-20543
Study First Received:	March 15, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00303758
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Pancreatic Neoplasms
Disease Progression
Endocrine System Diseases
Leucovorin
Pancrelipase
Recurrence
Calcium, Dietary
Digestive System Diseases

Cisplatin
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

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

ClinicalTrials.gov processed this record on January 16, 2009