Clinical trial NCT02827201: FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Keywords: pancreatic cancer
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
Collaborators: name: UNICANCER
name: GERCOR - Multidisciplinary Oncology Cooperative Group
First posted: 2016-07-11
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Overall Survival (OS):
timeFrame: Up to 2 years after the treatment start
measure: Best Response
timeFrame: Up to the end of treatment on the average of 12 months
measure: Progression-free Survival (PFS)
timeFrame: up to 12 months after randomization
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Privée Claude Bernard
city: Blois
country: France
facility: CH
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos
city: Boulogne sur Mer
country: France
facility: Hôpital Duchenne
city: Bourgoin-Jallieu
country: France
facility: CH Pierre Oudot
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHR côte de Nacre
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Dijon
country: France
facility: Centre GF Leclerc
city: Draguignan
country: France
facility: CH de la Dracénie
city: Flers
country: France
facility: Ch Jacques Monod
city: Frejus
country: France
facility: CH
city: Le Kremlin Bicetre
country: France
facility: CHU
city: Le Mans
country: France
facility: CH
city: Limoges
country: France
facility: CHU
city: Limoges
country: France
facility: Clinique Chenieux
city: Longjumeau -
country: France
facility: CH
city: Lyon
country: France
facility: CH Pierre Benite
city: Marseille
country: France
facility: Hopital Europeen Marseille
city: Mont-de-Marsan
country: France
facility: H Layné
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hôpital La Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Cochin
city: Perpignan
country: France
facility: CH St Jean
city: Pessac
country: France
facility: Hôpital Haut Lévèque
city: Plérin
country: France
facility: Centre Cario - Hpca Saint Brieuc
city: Romans Sur Isere
country: France
facility: Hôpitaux Drome Nord
city: Rouen
country: France
facility: CHU
city: Saint Grégoire
country: France
facility: CHP
city: Strasbourg
country: France
facility: Clinique Privée
city: Thonon Les Bains
country: France
facility: Hopitaux Du Leman
city: Toulouse
country: France
facility: Clinique Pasteur Groupe ONCORAD GARONNE
city: Toulouse
country: France
facility: Clinique Privée Pasteur
city: Toulouse
country: France
facility: Clinique Privée Saint Jean
city: Toulouse
country: France
facility: Clinique St Jean Languedoc
city: Villejuif
country: France
facility: Gustave Roussy
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
affiliation: HEGP - PARIS - FRANCE
name: Julien TAIEB, Pr
role: STUDY_CHAIR
References:
citation: 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.