NCT02827201

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_2

Geographic Reach
1 country

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 9, 2024

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

November 26, 2015

Results QC Date

December 22, 2022

Last Update Submit

July 5, 2024

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization

    The primary endpoint was the rate of patients alive and progression-free 6 months after randomization. Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites. Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months. The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.

    6 months after randomization

Secondary Outcomes (3)

  • Overall Survival (OS):

    Up to 2 years after the treatment start

  • Best Response

    Up to the end of treatment on the average of 12 months

  • Progression-free Survival (PFS)

    up to 12 months after randomization

Study Arms (2)

nab-paclitaxel + gemcitabine/FOLFIRI.3

EXPERIMENTAL

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.3Drug: nab-paclitaxel+ gemcitabine

nab-paclitaxel + gemcitabine

ACTIVE COMPARATOR

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

Interventions

FOLFIRI.3DRUG

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)

nab-paclitaxel + gemcitabine/FOLFIRI.3
nab-paclitaxel+ gemcitabineDRUG

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.

nab-paclitaxel + gemcitabinenab-paclitaxel + gemcitabine/FOLFIRI.3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Clinique Privée Claude Bernard

Albi, France

Location

CH

Blois, France

Location

Clinique Tivoli Ducos

Bordeaux, France

Location

Hôpital Duchenne

Boulogne-sur-Mer, France

Location

CH Pierre Oudot

Bourgoin, France

Location

Centre François Baclesse

Caen, France

Location

CHR côte de Nacre

Caen, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

Centre GF Leclerc

Dijon, France

Location

CH de la Dracénie

Draguignan, France

Location

Ch Jacques Monod

Flers, France

Location

CH

Fréjus, France

Location

CHU

Le Kremlin-Bicêtre, France

Location

CH

Le Mans, France

Location

CHU

Limoges, France

Location

Clinique Chenieux

Limoges, France

Location

CH

Longjumeau, France

Location

CH Pierre Benite

Lyon, France

Location

Hopital Europeen Marseille

Marseille, 13331, France

Location

H Layné

Mont-de-Marsan, France

Location

HEGP

Paris, 75020, France

Location

Hôpital La Pitié Salpêtrière

Paris, 75651, France

Location

Hôpital Cochin

Paris, France

Location

CH St Jean

Perpignan, France

Location

Hôpital Haut Lévèque

Pessac, France

Location

Centre Cario - Hpca Saint Brieuc

Plérin, France

Location

Hôpitaux Drome Nord

Romans-sur-Isère, France

Location

CHU

Rouen, France

Location

CHP

Saint-Grégoire, France

Location

Clinique Privée

Strasbourg, France

Location

Hopitaux Du Leman

Thonon-les-Bains, France

Location

Clinique Pasteur Groupe ONCORAD GARONNE

Toulouse, France

Location

Clinique Privée Pasteur

Toulouse, France

Location

Clinique Privée Saint Jean

Toulouse, France

Location

Clinique St Jean Languedoc

Toulouse, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Hôpital Paul Brousse

Villejuif, France

Location

Related Publications (1)

  • Rinaldi Y, Pointet AL, Khemissa Akouz F, Le Malicot K, Wahiba B, Louafi S, Gratet A, Miglianico L, Laharie H, Bouhier Leporrier K, Thirot Bidault A, Texereau P, Coriat R, Terrebonne E, Gouttebel MC, Malka D, Bachet JB, Lepage C, Taieb J; PRODIGE 37 Investigators/Collaborators. Gemcitabine plus nab-paclitaxel until progression or alternating with FOLFIRI.3, as first-line treatment for patients with metastatic pancreatic adenocarcinoma: The Federation Francophone de Cancerologie Digestive-PRODIGE 37 randomised phase II study (FIRGEMAX). Eur J Cancer. 2020 Sep;136:25-34. doi: 10.1016/j.ejca.2020.05.018. Epub 2020 Jul 2.

    PMID: 32623182RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Karine Le Malicot
Organization
Fédération Francophone de Cancérologie Digestive
karine.le-malicot@u-bourgogne.fr
+33 3 80 39 34 79

Study Officials

  • Julien TAIEB, Pr

    HEGP - PARIS - FRANCE

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2015

First Posted

July 11, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2017

Study Completion

March 1, 2021

Last Updated

July 9, 2024

Results First Posted

July 9, 2024

Record last verified: 2024-07

Locations

FR(37)