Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112658
• Other study ID #: CDR0000430100
• Secondary ID: FRE-FNCLCC-ACCOR
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2004
• Est. completion date: June 30, 2010

Study information

• Verified date: March 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy 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. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

Description:

OBJECTIVES:

Primary

• Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II)

• Compare the survival of patients treated with these regimens. (Phase III)

Secondary

• Compare the toxicity of these regimens in these patients.

• Compare progression-free survival of patients treated with these regimens. (Phase III)

• Compare the overall response rate in patients treated with these regimens. (Phase III)

• Compare quality of life of patients treated with these regimens. (Phase III)

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days.

• Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: June 30, 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• No other pancreatic tumor type, including either of the following:

• Neuroendocrine tumor

• Acinar cell tumor

• Metastatic disease

• Measurable disease in an area not previously irradiated

• No cerebral metastases or meningeal involvement of the tumor

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

Hepatic

• Bilirubin = 1.5 times upper limit of normal (biliary drainage allowed)

Renal

• Creatinine < 120 mmol/L

Cardiovascular

• No prior myocardial infarction

• No prior angina

• No uncompensated cardiac or coronary insufficiency

• No symptomatic arrhythmia

Gastrointestinal

• No prior inflammatory bowel disease

• No prior chronic diarrhea

• No unresolved symptomatic occlusion or subocclusion of the bowel

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No ongoing active infection

• No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No contraindication to study treatment

• No other serious medical disorder that would preclude study treatment

• No psychiatric disorder or social or geographic situation that would preclude study participation

• Not detained or under the guardianship of another person

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• No concurrent participation in another clinical trial using therapeutic experimental agents

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• fluorouracil

• gemcitabine hydrochloride

• irinotecan hydrochloride

• leucovorin calcium

• oxaliplatin

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens
France	Hopital Duffaut	Avignon
France	Centre Hospitalier General	Belfort
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
France	Hopital Avicenne	Bobigny
France	Hopital Saint Andre	Bordeaux
France	Institut Bergonie	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Centre Hospitalier Docteur Duchenne	Boulogne Sur Mer
France	Hopital Ambroise Pare	Boulogne-Billancourt
France	Centre Regional Francois Baclesse	Caen
France	CHU de Caen	Caen
France	Centre Jean Perrin	Clermont-Ferrand
France	CHR Clermont Ferrand, Hotel Dieu	Clermont-Ferrand
France	Hopitaux Civils de Colmar	Colmar
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Hopital Du Bocage	Dijon
France	Centre Hospitalier Intercommunal St. Aubin les Elbeuf	Elbeuf
France	Clinique Saint Vincent	Epernay
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	CMC Les Ormeaux	Le Havre
France	Centre Oscar Lambret	Lille
France	Hopital Saint Vincent de Paul	Lille
France	Polyclinique des Quatre Pavillons	Lormont
France	Centre Leon Berard	Lyon
France	Hopital de la Croix Rousse	Lyon
France	Hopital Edouard Herriot - Lyon	Lyon
France	CHU de la Timone	Marseille
France	CHU Nord	Marseille
France	Hopital Ambroise Pare	Marseille
France	Hopital Notre-Dame de Bon Secours	Metz
France	Centre Hospitalier General de Mont de Marsan	Mont-de-Marsan
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Centre Regional Rene Gauducheau	Nantes-Saint Herblain
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Saint Michel	Paris
France	Centre Hospitalier de Perpignan	Perpignan
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU - Robert Debre	Reims
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Hopital Charles Nicolle	Rouen
France	Clinique Armoricaine De Radiologie	Saint Brieuc
France	Centre Rene Huguenin	Saint Cloud
France	Clinique Charcot	Sainte Foy Les Lyon
France	Centre Hospitalier de Semur en Auxois	Semur en Auxois
France	Centre Paul Strauss	Strasbourg
France	Hopital Universitaire Hautepierre	Strasbourg
France	Centre Hospitalier de Tarbes	Tarbes
France	Institut Claudius Regaud	Toulouse
France	CHU de Tours	Tours
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (2)

Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux — View Citation

Ychou M, Desseigne F, Guimbaud R, et al.: Randomized phase II trial comparing folfirinox (5FU/leucovorin [LV], irinotecan [I] and oxaliplatin [O]) vs gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): first results of

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (Phase II)
Primary	Survival (Phase III)
Secondary	Toxicity
Secondary	Progression-free survival (Phase III)
Secondary	Quality of life (Phase III)
Secondary	Overall response rate (Phase III)