Clinical trial study comparing the efficiency of standard treatment, new treatment or in combinaison (sequentially every 2 month) in metastatic pancreatic cancer

Phase 1

• Conditions: Metastatic pancreatic cancer; MedDRA version: 20.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10052747Term: Adenocarcinoma pancreasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004309-41-FR
• Lead Sponsor: Fédération francophone de cancérologie digestive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Histopathologically proven pancreatic adenocarcinoma (on primitive or metastatic lesion)
18 = age = 75 years
Life expectancy >12 weeks
Performance status WHO < 2
No prior chemotherapy (adjuvant chemotherapy by gemcitabine +/- capecitabine is allowed if ended at least 12 months before the inclusion)
Pain well controlled before the inclusion of the patient
ANC = 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)
Adequate 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.
Albumin levels = 3.0 g/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN acceptable if liver metastases were present)
Normal renal function test (serum creatinine concentration = 120 µmol/l or creatinine clearance = 50 ml/min)
Normal ECG or ECG without any clinically significant findings
Patient able to understand and sign an informed consent
Females of child-bearing potential are required to test negative for pregnancy at the time of enrollment based on a urine or serum pregnancy test.
Both male and female patients of reproductive potential were required to agree to use a reliable method of birth control, during the study and for 3 months following the last dose of study drug.
Patient affiliated to social security
Regular follow-up possible

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 140

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Progression free survival (according to the investigator and central review) <br>Overall survival <br>Time to treatment failure <br>Safety <br>Quality of life (EORTC QLQ-C30)<br>CA 19-9 and CEA monitoring<br>;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