Metastatic pancreatic cancer MedDRA version: 20.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10052747 Term: Adenocarcinoma pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ONIVYDE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IRINOTECAN SUCROSOFATE
Current Sponsor code: Nal-IRI
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Fédération francophone de cancérologie digestive
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histopathologically proven pancreatic adenocarcinoma (on primitive or metastatic lesion) 18 = age = 75 years Life expectancy >12 weeks Performance status WHO =65 years) no F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: Known brain or bone metastasis (no need of systematic CT scan) Prior radiation therapy (except if there is at least one measurable target outside irradiation area) Clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > Grade 1 History of any second malignancy in the last 5 years; subjects with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they had been continuously disease free for at least 5 years. Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion. NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Known hypersensitivity to any of the drugs /constituents or non-lipososomal irinotecan Any other medical or social condition deemed by the investigator to be likely to interfere with a patient’s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results. Use of CYP3A4/UGT1A inducers/inhibitors Use of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for nab-paclitaxel or gemcitabine ILD presence Pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the progression free survival at 6 months in experimental arms (arm A: Nal-Iri plus 5FU/LV and Nab-Paclitaxel plus Gemcitabine alternatively, arm B: Nal-Iri plus 5FU/LV) VS the reference arm (arm C: Nab-Paclitaxel plus Gemcitabine);Secondary Objective: Best objective response rate Progression free survival (according to the investigator and central review) Overall survival Time to treatment failure Safety Quality of life (EORTC QLQ-C30) CA 19-9 and CEA monitoring ;Primary end point(s): The primary endpoint is the rate of patients alive without progression at 6 months after inclusion. The progression is defined as radiological and/or clinical progression assessed by the investigator according to RECIST v1.1 criteria. The delay will be defined from the date of randomization until progression or death (for whatever reason) or date of last news. ;Timepoint(s) of evaluation of this end point: 6 months after the last patient inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Best Objective Response (BOR): BOR is defined as complete or partial response rate according to scans and RECIST v1.1 criteria over the entire treatment period. Progression free survival (PFS): PFS is defined as the time between the date of randomization and the date of the first radiological and/or clinical progression or the date of death (for whatever reason). Patients living without progression will be censured at date of last news. Progression is assessed by investigator and central review according to RECIST v1.1 criteria. Overall survival (OS): OS is defined as the time between the date of randomization and the date of death (whatever the cause). Alive patients will be censured at date of last news. Time to treatment failure is defined as the time between the date of randomization and the date of discontinuation of all protocol treatments (regardless of cause) or date last news for patients alive under treatment. Safety: Toxicities are evaluated according to NCI-CTC v4.0. Quality of life (EORTC QLQ-C30): Quality of life will be assessed according to the questionnaire of EORTC QLQ-C30. This scale comprises 30 items with 15 dimensions for calculating 15 scores (5 functional ability scores, 8 symptom scores, an overall score, and a financial problems score). These scores will be calculated and described at inclusion. Of an exploratory manner, time to deterioration of the overall health score will be calculated: it is defined as the time interval between the date of randomization and the date of reduction of over 5 points compared to the baseline (5 points being considered the minimum to define a clinically significant difference) or death. Evolution of tumoral markers: The evolution of the markers will be analysed by a graphical representation at each time points of the percentage change from baseline.;Timepoint(s) of evaluation of this end point: One year after the last patient inclusion | — |
Countries
France
Contacts
Public ContactProject Manager
Fédération Francophone de Cancérologie Digestive
Outcome results
None listed