FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine (FIRGEMAX)
Primary Purpose
Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFIRI.3
nab-paclitaxel+ gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring pancreatic cancer
Eligibility 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
Sites / Locations
- Clinique Privée Claude Bernard
- CH
- Clinique Tivoli Ducos
- Hôpital Duchenne
- CH Pierre Oudot
- Centre François Baclesse
- CHR côte de Nacre
- Centre Hospitalier Sud Francilien
- Centre GF Leclerc
- CH de la Dracénie
- Ch Jacques Monod
- CH
- CHU
- CH
- CHU
- Clinique Chenieux
- CH
- CH Pierre Benite
- Hopital Europeen Marseille
- H Layné
- HEGP
- Hôpital La Pitié Salpêtrière
- Hôpital Cochin
- CH St Jean
- Hôpital Haut Lévèque
- Centre Cario - Hpca Saint Brieuc
- Hôpitaux Drome Nord
- CHU
- CHP
- Clinique Privée
- Hopitaux Du Leman
- Clinique Pasteur Groupe ONCORAD GARONNE
- Clinique Privée Pasteur
- Clinique Privée Saint Jean
- Clinique St Jean Languedoc
- Gustave Roussy
- Hôpital Paul Brousse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nab-paclitaxel + gemcitabine/FOLFIRI.3
nab-paclitaxel + gemcitabine
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Objective response rate (ORR)
Complete or partial response rates in imaging by RECIST v1.1 over the entire treatment period according the investigator
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.
Full Information
NCT ID
NCT02827201
First Posted
November 26, 2015
Last Updated
August 18, 2022
Sponsor
Federation Francophone de Cancerologie Digestive
Collaborators
UNICANCER, GERCOR - Multidisciplinary Oncology Cooperative Group
1. Study Identification
Unique Protocol Identification Number
NCT02827201
Brief Title
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
Acronym
FIRGEMAX
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federation Francophone de Cancerologie Digestive
Collaborators
UNICANCER, GERCOR - Multidisciplinary Oncology Cooperative Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nab-paclitaxel + gemcitabine/FOLFIRI.3
Arm Type
Experimental
Arm Description
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
Arm Title
nab-paclitaxel + gemcitabine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
FOLFIRI.3
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel+ gemcitabine
Intervention Description
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 Measure Information:
Title
Rate of patients alive without progression 6 months after inclusion
Description
The progression is clinically and/or radiologically assessed by the investigator (as defined in 1.1) according to RECIST v1.1 criteria.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival (OS):
Description
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
Time Frame
1 and 2 years
Title
Objective response rate (ORR)
Description
Complete or partial response rates in imaging by RECIST v1.1 over the entire treatment period according the investigator
Time Frame
6 months
Title
Progression-free survival:
Description
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.
Time Frame
1 and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien TAIEB, Pr
Organizational Affiliation
HEGP - PARIS - FRANCE
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique Privée Claude Bernard
City
Albi
Country
France
Facility Name
CH
City
Blois
Country
France
Facility Name
Clinique Tivoli Ducos
City
Bordeaux
Country
France
Facility Name
Hôpital Duchenne
City
Boulogne sur Mer
Country
France
Facility Name
CH Pierre Oudot
City
Bourgoin-Jallieu
Country
France
Facility Name
Centre François Baclesse
City
Caen
Country
France
Facility Name
CHR côte de Nacre
City
Caen
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil Essonnes
Country
France
Facility Name
Centre GF Leclerc
City
Dijon
Country
France
Facility Name
CH de la Dracénie
City
Draguignan
Country
France
Facility Name
Ch Jacques Monod
City
Flers
Country
France
Facility Name
CH
City
Frejus
Country
France
Facility Name
CHU
City
Le Kremlin Bicetre
Country
France
Facility Name
CH
City
Le Mans
Country
France
Facility Name
CHU
City
Limoges
Country
France
Facility Name
Clinique Chenieux
City
Limoges
Country
France
Facility Name
CH
City
Longjumeau -
Country
France
Facility Name
CH Pierre Benite
City
Lyon
Country
France
Facility Name
Hopital Europeen Marseille
City
Marseille
ZIP/Postal Code
13331
Country
France
Facility Name
H Layné
City
Mont-de-Marsan
Country
France
Facility Name
HEGP
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital La Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
CH St Jean
City
Perpignan
Country
France
Facility Name
Hôpital Haut Lévèque
City
Pessac
Country
France
Facility Name
Centre Cario - Hpca Saint Brieuc
City
Plérin
Country
France
Facility Name
Hôpitaux Drome Nord
City
Romans Sur Isere
Country
France
Facility Name
CHU
City
Rouen
Country
France
Facility Name
CHP
City
Saint Grégoire
Country
France
Facility Name
Clinique Privée
City
Strasbourg
Country
France
Facility Name
Hopitaux Du Leman
City
Thonon Les Bains
Country
France
Facility Name
Clinique Pasteur Groupe ONCORAD GARONNE
City
Toulouse
Country
France
Facility Name
Clinique Privée Pasteur
City
Toulouse
Country
France
Facility Name
Clinique Privée Saint Jean
City
Toulouse
Country
France
Facility Name
Clinique St Jean Languedoc
City
Toulouse
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Hôpital Paul Brousse
City
Villejuif
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
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