FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine (FIRGEMAX)

Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer

The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.

Study Overview

• Status: Completed
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: FOLFIRI.3; Drug: nab-paclitaxel+ gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Albi, France
    • Clinique Privée Claude Bernard
  • Blois, France
    • CH
  • Bordeaux, France
    • Clinique Tivoli Ducos
  • Boulogne sur Mer, France
    • Hôpital Duchenne
  • Bourgoin-Jallieu, France
    • CH Pierre Oudot
  • Caen, France
    • Centre Francois Baclesse
  • Caen, France
    • CHR côte de Nacre
  • Corbeil Essonnes, France
    • Centre Hospitalier Sud Francilien
  • Dijon, France
    • Centre GF Leclerc
  • Draguignan, France
    • CH de la Dracénie
  • Flers, France
    • CH Jacques Monod
  • Frejus, France
    • CH
  • Le Kremlin Bicetre, France
    • CHU
  • Le Mans, France
    • CH
  • Limoges, France
    • CHU
  • Limoges, France
    • Clinique Chenieux
  • Longjumeau -, France
    • CH
  • Lyon, France
    • CH Pierre Benite
  • Marseille, France, 13331
    • Hopital Europeen Marseille
  • Mont-de-Marsan, France
    • H Layné
  • Paris, France
    • Hopital Cochin
  • Paris, France, 75651
    • Hôpital La Pitié Salpêtrière
  • Paris, France, 75020
    • HEGP
  • Perpignan, France
    • CH St Jean
  • Pessac, France
    • Hopital Haut Leveque
  • Plérin, France
    • Centre Cario - Hpca Saint Brieuc
  • Romans Sur Isere, France
    • Hopitaux Drome Nord
  • Rouen, France
    • CHU
  • Saint Grégoire, France
    • CHP
  • Strasbourg, France
    • Clinique privée
  • Thonon Les Bains, France
    • Hopitaux du Leman
  • Toulouse, France
    • Clinique Pasteur Groupe ONCORAD GARONNE
  • Toulouse, France
    • Clinique Privée Pasteur
  • Toulouse, France
    • Clinique Privée Saint Jean
  • Toulouse, France
    • Clinique St Jean Languedoc
  • Villejuif, France, 94805
    • Gustave Roussy
  • Villejuif, France
    • Hôpital Paul Brousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histological or cytological confirmation of pancreatic adenocarcinoma
• Distant metastatic disease
• Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
• At least one lesion measurable by RECIST v1.1 criteria
• Life expectancy> 3 months
• No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
• No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
• Pain must be monitored before inclusion
• 18 years < age < 75
• Performance status: WHO < 2
• ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
• ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
• Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
• Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
• Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose
• Patient affiliated to the social security scheme
• Patient information and signature of informed consent

Exclusion Criteria:

• - Other types of pancreatic tumours, especially endocrine or acinar cell tumours
• Ampulloma
• Presence of meningeal or cerebral metastases, bone metastases
• Gilbert's syndrome
• Presence of neuropathy> grade 1 according to NCIC-CTC 4.0
• Contraindications specific to the studied treatments
• History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
• Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured
• Significant history of heart or respiratory disease, including any history of interstitial pneumonia
• Patient already included in another clinical trial with an experimental molecule
• Women who are breast-feeding
• Persons deprived of liberty or under guardianship
• Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: nab-paclitaxel + gemcitabine/FOLFIRI.3; Alternance of : 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free); follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression	Drug: FOLFIRI.3; For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over); Drug: nab-paclitaxel+ gemcitabine; For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
ACTIVE_COMPARATOR: nab-paclitaxel + gemcitabine; nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression	Drug: nab-paclitaxel+ gemcitabine; For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients alive without progression 6 months after inclusion	The progression is clinically and/or radiologically assessed by the investigator (as defined in 1.1) according to RECIST v1.1 criteria.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS):	Time interval between the randomisation date and the date of death (all causes). The patients alive will be censored at the end-point or the date of the latest event	1 and 2 years
Objective response rate (ORR)	Complete or partial response rates in imaging by RECIST v1.1 over the entire treatment period according the investigator	6 months
Progression-free survival:	Time interval between the randomisation date and the date of first progression (clinical and/or radiological) or death (whatever the cause). Living patients without progression will be censored at the end-point or date of latest event.	1 and 2 years

Collaborators and Investigators

• Sponsor: Federation Francophone de Cancerologie Digestive
• Collaborators: UNICANCER; GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Study Chair: Julien TAIEB, Pr, HEGP - Paris - France

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): March 1, 2021

Study Registration Dates

• First Submitted: November 26, 2015
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (ESTIMATE): July 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel
• Other Study ID Numbers: PRODIGE 37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED