FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Drug: FOLFIRI.3
- Registration Number
- NCT02827201
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- 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
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- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nab-paclitaxel + gemcitabine/FOLFIRI.3 nab-paclitaxel+ gemcitabine 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 + gemcitabine 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 nab-paclitaxel + gemcitabine/FOLFIRI.3 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
- Primary Outcome Measures
Name Time Method Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization 6 months after 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.
- Secondary Outcome Measures
Name Time Method Best Response Up to the end of treatment on the average of 12 months 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
Progression-free Survival (PFS) up to 12 months after randomization 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
Overall Survival (OS): Up to 2 years after the treatment start 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
Trial Locations
- Locations (32)
Centre François Baclesse
🇫🇷Caen, France
Clinique Privée Claude Bernard
🇫🇷Albi, France
CH
🇫🇷Longjumeau -, France
Clinique Tivoli Ducos
🇫🇷Bordeaux, France
Hôpital Duchenne
🇫🇷Boulogne sur Mer, France
CH Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Centre Hospitalier Sud Francilien
🇫🇷Corbeil Essonnes, France
Centre GF Leclerc
🇫🇷Dijon, France
CHU
🇫🇷Rouen, France
CH de la Dracénie
🇫🇷Draguignan, France
Ch Jacques Monod
🇫🇷Flers, France
Clinique Chenieux
🇫🇷Limoges, France
Hopital Europeen Marseille
🇫🇷Marseille, France
CH Pierre Benite
🇫🇷Lyon, France
HEGP
🇫🇷Paris, France
Hôpital La Pitié Salpêtrière
🇫🇷Paris, France
H Layné
🇫🇷Mont-de-Marsan, France
Hôpital Cochin
🇫🇷Paris, France
CH St Jean
🇫🇷Perpignan, France
Centre Cario - Hpca Saint Brieuc
🇫🇷Plérin, France
Hôpital Haut Lévèque
🇫🇷Pessac, France
Clinique Privée
🇫🇷Strasbourg, France
Hôpitaux Drome Nord
🇫🇷Romans Sur Isere, France
CHP
🇫🇷Saint Grégoire, France
Hopitaux Du Leman
🇫🇷Thonon Les Bains, France
Clinique Privée Pasteur
🇫🇷Toulouse, France
Clinique Pasteur Groupe ONCORAD GARONNE
🇫🇷Toulouse, France
Clinique Privée Saint Jean
🇫🇷Toulouse, France
Gustave Roussy
🇫🇷Villejuif, France
Clinique St Jean Languedoc
🇫🇷Toulouse, France
Hôpital Paul Brousse
🇫🇷Villejuif, France
CHR côte de Nacre
🇫🇷Caen, France