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

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ClinicalTrials.gov Identifier: NCT02827201
Recruitment Status : Active, not recruiting
First Posted : July 11, 2016
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
UNICANCER
GERCOR - Multidisciplinary Oncology Cooperative Group
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: FOLFIRI.3 Drug: nab-paclitaxel+ gemcitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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.




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


Secondary Outcome Measures :
  1. Overall survival (OS): [ Time Frame: 1 and 2 years ]
    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

  2. Objective response rate (ORR) [ Time Frame: 6 months ]
    Complete or partial response rates in imaging by RECIST v1.1 over the entire treatment period

  3. Best response to treatment [ Time Frame: 6 months ]
    shall be evaluated from imaging throughout the treatment

  4. Progression-free survival: [ Time Frame: 1 and 2 years ]
    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.

  5. Toxicities are evaluated according to NCI CTC v4.0. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827201


Locations
France
Clinique Privée Claude Bernard
Albi, France
CH
Blois, France
Clinique Tivoli Ducos
Bordeaux, France
Hôpital Duchenne
Boulogne sur Mer, France
CH Pierre Oudot
Bourgoin-Jallieu, France
Centre François Baclesse
Caen, France
CHR côte de Nacre
Caen, France
Centre Hospitalier Sud Francilien
Corbeil Essonnes, France
Centre GF Leclerc
Dijon, France
CH de la Dracénie
Draguignan, France
Ch Jacques Monod
Flers, France
CH
Frejus, France
CHU
Le Kremlin Bicetre, France
CH
Le Mans, France
CHU
Limoges, France
Clinique Chenieux
Limoges, France
CH
Longjumeau -, France
CH Pierre Benite
Lyon, France
Hopital Europeen Marseille
Marseille, France, 13331
H Layné
Mont-de-Marsan, France
HEGP
Paris, France, 75020
Hôpital La Pitié Salpêtrière
Paris, France, 75651
Hôpital Cochin
Paris, France
CH St Jean
Perpignan, France
Hôpital Haut Lévèque
Pessac, France
Centre Cario - Hpca Saint Brieuc
Plérin, France
Hôpitaux Drome Nord
Romans Sur Isere, France
CHU
Rouen, France
CHP
Saint Grégoire, France
Clinique Privée
Strasbourg, France
Hopitaux Du Leman
Thonon Les Bains, France
Clinique Pasteur Groupe ONCORAD GARONNE
Toulouse, France
Clinique Privée Pasteur
Toulouse, France
Clinique Privée Saint Jean
Toulouse, France
Clinique St Jean Languedoc
Toulouse, France
Gustave Roussy
Villejuif, France, 94805
Hôpital Paul Brousse
Villejuif, France
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
UNICANCER
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
Study Chair: Julien TAIEB, Pr HEGP - PARIS - FRANCE

Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT02827201     History of Changes
Other Study ID Numbers: PRODIGE 37
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Federation Francophone de Cancerologie Digestive:
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs