Abstract 1566TiP
Background
After failure to FOLFIRINOX or gemcitabine + nab-paclitaxel combination, no clinical trial evaluated prospectively the benefit of a second line chemotherapy. Phases III clinical studies currently available enrolled only patients who progressed under gemcitabine treatment. It does not exist any strong argument in favor of or against actual place of second line chemotherapy after failure to first line FOLFIRINOX or gemcitabine + nab-paclitaxel therapy. Potential usefulness of taxanes was demonstrated with nab-paclitaxel. However, the potential efficacy of docetaxel or paclitaxel in metastatic pancreas cancer was evaluated only in small non-randomized studies and mainly after failure to first line gemcitabine. Thus, taking into account the absence of second line prospective studies, a similar mechanism of action between nab-paclitaxel and paclitaxel, and a reduced cost of paclitaxel, our study aims to evaluate the combination of gemcitabine + paclitaxel in the treatment of metastatic pancreas cancer after failure or intolerance to FOLFIRINOX.
Trial design
Comparative, multicentric, phase III randomized, open-label trial enrolling patients ≥18 years, with metastatic pancreatic ductal adenocarcinoma, ECOG performance status 0-2, after failure or intolerance of first line FOLFIRINOX therapy. The primary objective of the study is to evaluate the superiority of the combination of gemcitabine + paclitaxel over gemcitabine monotherapy in terms of overall survival (OS) (8 months vs 5 months with HR=0,625). Main secondary criteria are progression-free survival, disease control rate at 4 months, objective response rate, safety, and quality of life. Paclitaxel 80 mg/m2 and gemcitabine 1000 mg/m2 will be given at day 1, day 8, and day 15, followed by one week of rest, every 28 days. 184 events (deaths) would have 85% power to show statistically significant OS at a 2-sided 5% alpha. 210 patients will be randomized (70 patients in the control arm and 140 patients in the experimental arm). We programmed an interim analysis of efficacy to be performed after half of the planned events will have occurred.
Clinical trial identification
NCT03943667.
Editorial acknowledgement
Legal entity responsible for the study
UNICANCER.
Funding
Institut National du Cancer (INCa).
Disclosure
C. de la Fouchardiere: Advisory/Consultancy, Travel/Accommodation/Expenses: Servier; Advisory/Consultancy: Bayer; Advisory/Consultancy: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Pierre Fabre Oncologie; Advisory/Consultancy, Travel/Accommodation/Expenses: Eisai; Advisory/Consultancy: MSD; Travel/Accommodation/Expenses: Amgen; Travel/Accommodation/Expenses: BMS. J. Raimbourg: Travel/Accommodation/Expenses: Bayer; Travel/Accommodation/Expenses: Leo Pharma; Honoraria (self): Takeda; Honoraria (self): BMS; Honoraria (self): Novartis; Honoraria (self): Amgen. F. Ghiringhelli: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Astra Zeneca; Honoraria (self): Merck Serono; Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self), Travel/Accommodation/Expenses: Amgen; Honoraria (self): Bayer; Honoraria (self), Travel/Accommodation/Expenses: Servier. M. Jary: Travel/Accommodation/Expenses: Roche. T. Aparicio: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony: Ipsen; Speaker Bureau/Expert testimony: Amgen; Speaker Bureau/Expert testimony, Officer/Board of Directors: Servier; Speaker Bureau/Expert testimony: Sanofi; Officer/Board of Directors: Bioven; Travel/Accommodation/Expenses: Bayer. F. Hociné: Advisory/Consultancy: Merck; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Novartis; Advisory/Consultancy: Janssen; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Ipsen; Advisory/Consultancy: BMS; Advisory/Consultancy: Chugai. C. Neuzillet: Advisory/Consultancy: Servier; Advisory/Consultancy, Clinical Trials Investigator: AstraZeneca; Advisory/Consultancy, clinical trials investigator: BMS; Advisory/Consultancy: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Incyte; Advisory/Consultancy: Nutricia; Advisory/Consultancy: Baxter; Advisory/Consultancy, Travel/Accommodation/Expenses: Mylan; Travel/Accommodation/Expenses, clinical trials investigator: OSE Immunotherapeutics; Research grant/Funding (institution), Travel/Accommodation/Expenses: ROCHE. D. Botsen: Travel/Accommodation/Expenses: Gsk; Honoraria (self): Pierre Fabre; Honoraria (self): Sanofi; Honoraria (self): Chugai; Travel/Accommodation/Expenses: Amgen; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Servier. J.M. Phelip: Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy: Celgene. P. Michel: Advisory/Consultancy: Servier; Advisory/Consultancy: Bayer; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Amgen; Advisory/Consultancy: Merck. L. Dahan: Honoraria (self): BMS; Honoraria (self): Sanofi; Honoraria (self): Amgen; Honoraria (self): Servier; Travel/Accommodation/Expenses: Roche. All other authors have declared no conflicts of interest.