Metastatic Pancreatic Ductal Adenocarcinoma
Conditions
Interventions
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equa
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC). 2. Age =18 years old. 3. At least one evaluable lesion according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) outside any previously irradiated area. 4. Failure of first line FOLFIRINOX therapy due to progressive disease during or within 3 months after the end of therapy (including mFOLFIRINOX in adjuvant setting) or patient with FOLFIRINOX intolerance 5. Performance Status (PS) ECOG 0 to 2. 6. Life expectancy =12 weeks. 7. Negative serology (HIV, hepatitis B and C) 8. Adequate organs function: - Absolute neutrophils count =1.5x109/L - Platelets count =100x109/L - Haemoglobin =9 g/dl - Serum bilirubin levels =65 years) no F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Any other primary tumor or secondary malignancy except basal cell carcinoma of the skin or in situ carcinoma of the cervix uteri (patients adequately treated for other malignancies and without tumor during the last 5 years are eligible). 2. Known cerebral metastasis. 3. Uncontrolled severe infections. 4. Patients with Kaposi’s sarcoma 5. Peripheral neuropathy exceeding CTCAE (Common Terminology Criteria for Adverse Events) v5.0 grade 2. 6. Previous treatment with taxane. 7. Patients with known allergy or severe hypersensitivity to any of the trial drugs or any of the trial drug excipients 8. Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment. 9. 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. 10. Participation in another clinical trial within 14 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the superiority in terms Overall Survival (OS) of gemcitabine + solvent-based (sb)-paclitaxel over gemcitabine alone in metastatic pancreatic ductal adenocarcinoma after FOLFIRINOX failure or intolerance.;Secondary Objective: The secondary objectives are the evaluation of: - The efficacy of the treatments in terms of: *Objective Response rate (according to RECIST 1.1) (ORR) *Progression-Free Survival (PFS) *Disease Control Rate at 4 months (4m-DCR) - Prognostic and predictive values of several biomarkers (Ca 19-9, CEA, neutrophil to lymphocyte ratio, albumin, Glasgow prognostic score) - Dose intensity of chemotherapy - Safety and tolerability of treatment (NCI-CTCAE version 5.0) - The effect of treatments on Quality of Life - The rate of subsequent chemotherapy (after progression) - Potential new biomarkers that may provide relevant information for clinicians as to whether the patients benefit from chemotherapy and to study the biomarkers dynamics across time and their association with primary and secondary endpoints of the trial.;Primary end point(s): Overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient is alive at the database cut-off date, then the patient will be censored at the last date of follow-up;Timepoint(s) of evaluation of this end point: _ | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy objective: *ORR (according to RECIST 1.1 criteria) defined as the percentage of patients with Complete Response (CR) or Partial Response (PR). Patients who discontinue treatment without a tumour assessment will be considered non-responders for the analysis *PFS defined as the time from the date of randomisation to date of disease progression (radiological or clinical) or death from any cause, whichever occurs first. Patients without tumour progression or death at the time of analysis will be censored at the date of their last tumour assessment. *4m-DCR is defined as proportion of patients with CR, PR, or a stable disease (SD), 4 months after treatment initiation. - Value of biomarkers (Ca 19-9, CEA, Lymphocyte to Neutrophil ratio, albumin, Glasgow prognostic score) will be described by absolute or relative variation from baseline. To assess their prognostic or predictive values, baseline values of these biomarkers will be tested using Cox or logistic regression models. - Dose intensity of chemotherapy will be calculated from doses actually given instead of from targeted doses. Ratio between dose received compared to theoretical ones will be calculated by patient and presented as a percentage. - Safety and tolerability of treatment (NCI-CTCAE version 5.0) determined through the incidence of adverse events, treatment related adverse events, serious adverse Events (SAE), and death. - Quality of life (EORTC QLQ-C30) during treatment. A deterioration of scores for five-targeted dimensions: pain, physical and emotional functioning, fatigue, and appetite will be compared between the two treatment arms, while other dimensions will be regarded as exploratory. 5 point deterioration in HRQoL scores will be considered as the minimal clinically important difference (MCID). - Rate of subsequent chemotherapy (after progression). The type and the date of beginning of first-cycle of each line will be collected. - Translational resear | — |
Countries
France
Contacts
Public ContactProject Manager
UNICANCER
Outcome results
None listed