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Metastatic Pancreatic CancerPhase 2FIRGEMAXNCT02827201

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

A Phase 2 study testing FOLFIRI.3 and nab-paclitaxel+ gemcitabine in people with Metastatic Pancreatic Cancer, run by Federation Francophone de Cancerologie Digestive at 37 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
FOLFIRI.3 and nab-paclitaxel+ gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
37 sitesFrance
Study dates
Nov 2015to Mar 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • - 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
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  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • Clinique Privée Claude Bernard

    Albi

  • CH

    Blois

  • Clinique Tivoli Ducos

    Bordeaux

  • Hôpital Duchenne

    Boulogne-sur-Mer

  • CH Pierre Oudot

    Bourgoin

  • Centre François Baclesse

    Caen

  • CHR côte de Nacre

    Caen

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes

  • Centre GF Leclerc

    Dijon

  • CH de la Dracénie

    Draguignan

  • Ch Jacques Monod

    Flers

  • CH

    Fréjus

  • CHU

    Le Kremlin-Bicêtre

  • CH

    Le Mans

  • CHU

    Limoges

  • Clinique Chenieux

    Limoges

  • CH

    Longjumeau

  • CH Pierre Benite

    Lyon

  • Hopital Europeen Marseille

    Marseille, 13331

  • H Layné

    Mont-de-Marsan

  • HEGP

    Paris, 75020

  • Hôpital La Pitié Salpêtrière

    Paris, 75651

  • Hôpital Cochin

    Paris

  • CH St Jean

    Perpignan

  • Hôpital Haut Lévèque

    Pessac

  • Centre Cario - Hpca Saint Brieuc

    Plérin

  • Hôpitaux Drome Nord

    Romans-sur-Isère

  • CHU

    Rouen

  • CHP

    Saint-Grégoire

  • Clinique Privée

    Strasbourg

  • Hopitaux Du Leman

    Thonon-les-Bains

  • Clinique Pasteur Groupe ONCORAD GARONNE

    Toulouse

  • Clinique Privée Pasteur

    Toulouse

  • Clinique Privée Saint Jean

    Toulouse

  • Clinique St Jean Languedoc

    Toulouse

  • Gustave Roussy

    Villejuif, 94805

  • Hôpital Paul Brousse

    Villejuif

Other trials in France

About this study

Official title: 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.

Being tested
FOLFIRI.3, nab-paclitaxel+ gemcitabine
Keywords
pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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+ 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.

Study groups in NCT02827201
Study groupRoleWhat they receive
nab-paclitaxel + gemcitabine/FOLFIRI.3ExperimentalAlternance 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
Receives: Drug: FOLFIRI.3; Drug: nab-paclitaxel+ gemcitabine
nab-paclitaxel + gemcitabineActive comparatornab-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
Receives: Drug: nab-paclitaxel+ gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after randomization

Secondary outcomes (3)

  1. Overall Survival (OS):

    Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account

    Measured: Up to 2 years after the treatment start

  2. Best Response

    Best response is defined as the best response for each patient regarding imagerie taken during the treatment. Response was evalauted according to RECIST v1.1 over the entire treatment period according the investigator

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

  3. Progression-free Survival (PFS)

    It was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news

    Measured: up to 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionDec 2017
  4. Study completionMar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02827201
Sponsor's protocol ID
PRODIGE 37
Acronym
FIRGEMAX
Status last verified
Jul 2024
First submitted
26 Nov 2015
Last updated
9 Jul 2024
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32623182

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRI.3 and nab-paclitaxel+ gemcitabine in people with Metastatic Pancreatic Cancer, run by Federation Francophone de Cancerologie Digestive at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02827201, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.

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