First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem

Metastatic Pancreatic Cancer Clinical Trial

— PANOPTIMOX  

Official title:

Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352337
• Other study ID #: PRODIGE35
• Status: Completed
• Phase: Phase 2
• Start date: December 23, 2014
• Est. completion date: August 2021

Study information

• Verified date: August 2022
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy. Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin. These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years. FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment. The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: August 2021
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic disease
• At least one mesurable lesion according to RECIST V1.1 criteria
• No prior chemotherapy (excepted if there is at least on lestion out of the irradition area)
• Age > 18 years. A favorable adviced by an onco geriatrician would be mandatory for inclusion of patients older than 75 older
• Performance statut (WHO) 0-1
• Polynyclear = 1500/mm3
• Bilirubine = 1,5 fois la LSN, creatinin < 120µmol / L
• Signed informed consent form

Exclusion Criteria:

• Another type of pancreas tumor, as endocrine tumor ou with acinous cells
• Ampulloma
• Cerebral or meningeal metastasis
• Gilbert disease
• Neuropathie > or = grade 1
• Study treatments contraindication
• Uncontrolled diarrhoea or inflamatory disease of colon or rectum, or bowel obstruction or bowel sub-obstruction no resolved with specific treatment
• Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease prevent patient to receive study Cancer within the 5 years before inclusion, except for int situ cancer of the neck of the uterus or basal cell skin cancer
• Significant previous cardiac and respiratory disease
• Patient included in an other therapeutic study with experimental treatment
• Pregnancy or breast feeding
• Patient depreved of freedom or under gardianship
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• FOLFIRINOX
Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue
• LV5FU2
Perfusion: Folinic Acid,5FU Bolus,5FU continue
• FOLFIRI.3
Perfusion :Irinotecan,Acide folinique ,5FU continue
• Gemcitabine
Gemcitabine perfusion

Locations

Country	Name	City	State
France	CHU - Hôtel Dieu	Angers
France	CH	Auxerre
France	CH - Henri Duffaut	Avignon
France	Centre d'oncologie et de radiothérapie	Bayonne
France	CH	Bayonne
France	Ch - Ch Beauvais	Beauvais
France	CHU	Besançon
France	Bezier Ch	Béziers
France	Hôpital Avicenne	Bobigny
France	Polyclinique Bordeaux Nord	Bordeaux
France	CH -Duchenne	Boulogne-sur-Mer
France	CHU Côte de Nacre	Caen
France	CHU Estaing	Clermont Ferrand
France	Hôpitaux Civils de Colmar	Colmar
France	CH Compiègne-Noyon	Compiègne
France	CHG	Corbeil-Essonnes
France	CHU - Hôpital François Mitterand	Dijon
France	CH	Dunkerque
France	CHU de Grenoble	Grenoble
France	Institut Daniel Hollard / Groupe Hospitalier Mutualiste	Grenoble
France	Clinique Sainte Marguerite	Hyeres
France	CH Marne La Vallée Jossigny	Jossigny
France	CHD	La Roche Sur Yon
France	CHU - Claude Huriez	Lille
France	Hôpital du Scorff	Lorient
France	CHU - Hôpital Edouard Herriot	Lyon
France	Clinique de la Sauvegarde	Lyon
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Privé Jean Mermoz	Lyon
France	Hôpital Européen de Marseille	Marseille
France	Hôpital privé	Marseille
France	La Timone	Marseille
France	CH - Centre Hospitalier de Meaux	Meaux
France	Centre Antoine Lassagne	Nice
France	Hôpital de la Source -service HGE et cancérologie digestive	Orléans
France	Hôpital de la Source- service d'oncologie	Orléans
France	CHU AP - HP - Hôpital Européen Georges Pompidou	Paris
France	Groupe Hospitalier Saint Joseph	Paris
France	Hôpital La Pitié Salpetière	Paris
France	CH Pau	Pau
France	Centre Hospitalier Annecy Genevois	Pringy
France	CHU Robert Debré	Reims
France	Centre Eugène Marquis	Rennes
France	CHU - Charles Nicolle	Rouen
France	CHU	Saint-Etienne
France	CH	Saint-Malo
France	CH	Soissons
France	Centre Paul Strauss	Strasbourg
France	Clinique Sainte Anne	Strasbourg
France	CH - Bigorra	Tarbes
France	Hôpityal Trousseau	Tours
France	CH	Valenciennes
France	Institut Gustave Roussy	Villejuif
France	Hôpital Privé de Villeneuve d'Ascq	Villeneuve D'Ascq

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients alive and without radiological and/or clinical progression	Progression is defined as radiological (RECIST v1.1) and/or clinical according to the investigator. Progression or death (whatever the reason is) will be taking into account if the event occurs during the 6 first months of treatment.	6 months after randomization
Secondary	Time to progression during the maintenance of treatment		After randomization
Secondary	Overall survival		2 years
Secondary	Progression survival		2 years