Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma

Inclusion criteria

• Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof
• Age ≥18 years
• At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area
• Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days)
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2
• Life expectancy ≥12 weeks
• Negative serology (HIV, hepatitis B and C)
• Adequate organs function
• Proven Post-menopausal status or negative urinary or serum pregnancy test
• Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment
• Patients affiliated to the social security system
• Patient must have signed a written informed consent form

Exclusion criteria

• Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri
• Known cerebral metastasis
• Uncontrolled severe infections
• Patients with Kaposi's sarcoma
• Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
• Previous treatment with taxane and/or gemcitabine (for pancreas cancer only)
• Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient
• Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment
• Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial
• Participation in another clinical trial within 14 days prior to randomization
• Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced