PACLITAXEL for Metastatic pancreatic cancer | Pancreatic adenocarcinoma

Inclusion criteria

• {"criterion_text":"-\tHistopathologically or cytologically proven pancreatic adenocarcinoma (on primitive or metastatic lesion)"}
• {"criterion_text":"-\tNormal ECG or ECG without any clinically significant findings"}
• {"criterion_text":"-\tPatient able to understand and sign an informed consent"}
• {"criterion_text":"-\tFemales of child-bearing potential are required to test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test."}
• {"criterion_text":"-\tBoth male and female patients of reproductive potential were required to agree to use a reliable method of birth control, during the study and for 7 months following the last dose of study drug."}
• {"criterion_text":"-\tPatient affiliated to social security -\tRegular follow-up possible"}
• {"criterion_text":"-\tMetastatic disease at a distance"}
• {"criterion_text":"-\tAt least one measurable lesion according RECIST v1.1 criteria"}
• {"criterion_text":"-\t18 ≤ age ≤ 75 years -\tLife expectancy >12 weeks -\tPerformance status WHO < 2"}
• {"criterion_text":"-\tNo prior chemotherapy: adjuvant chemotherapy by gemcitabine +/- capecitabine is allowed if ended at least 12 months before the inclusion and adjuvant or neo-adjuvant FOLRIFINOX chemotherapy is allowed if ended at least 12 months prior the inclusion"}
• {"criterion_text":"-\tPain well controlled before the inclusion of the patient"}
• {"criterion_text":"-\tANC ≥ 1,500 cells/μL (without the use of hematopoietic growth factors); platelet count ≥ 100,000 cells/μL, hemoglobin ≥ 9 g/dL (blood transfusions is permitted for patients with hemoglobin levels below 9 g/dL)"}
• {"criterion_text":"-\tAdequate hepatic function as evidenced by: Serum total bilirubin within normal range for the institution (Serum bilirubin ≤ 1,5 UNL) Biliary drainage allowed for biliary obstruction."}
• {"criterion_text":"-\tAlbumin levels ≥ 3.0 g/dL -\tAspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN acceptable if liver metastases were present) -\tNormal renal function test (creatinine clearance ≥ 50 ml/min)"}

Exclusion criteria

• {"criterion_text":"-\tUncontrolled brain or meningeal metastasis, or bone metastasis (no need of systematic CT scan)"}
• {"criterion_text":"-\tNYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure."}
• {"criterion_text":"-\tKnown hypersensitivity to any of the drugs /constituents or non-lipososomal irinotecan"}
• {"criterion_text":"-\tAny 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"}
• {"criterion_text":"-\tUse of CYP3A4/UGT1A inducers/inhibitors"}
• {"criterion_text":"-\tUse of strong CYP2C8 inhibitors or inducers, or presence of any other contraindications for nab-paclitaxel or gemcitabine"}
• {"criterion_text":"-\tILD presence"}
• {"criterion_text":"-\tPartial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)"}
• {"criterion_text":"-\tPregnant or breast feeding"}
• {"criterion_text":"-\tPrior radiation therapy (except if there is at least one measurable target outside irradiation area)"}
• {"criterion_text":"-\tClinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > Grade 1"}
• {"criterion_text":"-\tHistory of chronic inflammatory bowel disease"}
• {"criterion_text":"-\tOther types of pancreatic tumours, in particular endocrine or acinar cell tumours"}
• {"criterion_text":"-\tAmpulloma -\tGilbert's syndrome"}
• {"criterion_text":"-\tPresence of neuropathy > grade 1 according to NCI-CTC"}
• {"criterion_text":"-\tHistory 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."}
• {"criterion_text":"-\tSevere arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the rate of patients alive without progression at 6 months after inclusion","definition_or_measurement_approach":"Rate of patients alive without progression at 6 months after inclusion; main objective specifies assessment according to RECIST 1.1 criteria."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as complete or partial response rate according to imaging and RECIST v1.1 over the entire treatment period."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Time from randomization to first radiological and/or clinical progression or death (any cause)."}
• {"endpoint_text":"- Overall survival (OS): OS is defined as the time between the date of randomization and the date of death (whatever the cause).","definition_or_measurement_approach":"Time from randomization to death from any cause."}
• {"endpoint_text":"- Depth of response: This is defined as the relative difference between the sum of the largest diameters of target lesions in the NADIR (in the absence of new lesions or progression of non-target lesions) and the sum of the largest diameters of the target lesions at inclusion.","definition_or_measurement_approach":"Relative difference between sum of largest diameters at nadir versus at inclusion (no new lesions or non-target progression)."}
• {"endpoint_text":"- Early tumor shrinkage: This is defined as the relative difference between the sum of the largest diameters of target lesions at 8 weeks and this sum at inclusion. Early decrease corresponds to a relative difference of > 20% in RECIST v1.1.","definition_or_measurement_approach":"Relative difference between sum of largest diameters at 8 weeks vs inclusion; early decrease defined as >20% per RECIST v1.1."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time from randomization to discontinuation of all protocol treatments (any cause) or last follow-up for patients still on treatment."}
• {"endpoint_text":"- Safety: Toxicities are evaluated according to NCI-CTC v4.0.","definition_or_measurement_approach":"Adverse events/toxicities graded per NCI-CTC v4.0."}
• {"endpoint_text":"- Quality of life (EORTC QLQ-C30): Quality of life will be assessed according to the questionnaire of EORTC QLQ-C30","definition_or_measurement_approach":"Quality of life measured using the EORTC QLQ-C30 questionnaire."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Graphical analysis of percent change from baseline of tumour markers (e.g., CA19-9, CEA) at each time point."}

France

Earliest CTIS Part Ii Submission Date

15-10-2024

Latest Decision Or Authorization Date

15-10-2025

Processing Time Days

365

Number Of Sites

3

Number Of Participants

288

Primary sponsor

Full Name

Fondation Franc.Cancerologie Digestive

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France