Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer

Clinical Trial Description

Pancreatic cancer is the third leading cause of cancer death in 2016, surpassing breast cancer. It is estimated that by 2030 pancreatic cancer will become the second leading cause of cancer death after lung cancer. Its prognosis is very poor, with a 5-year overall survival rate (OS) at all stages of 5.5%. In France, its incidence doubled in men and tripled in women between 1982 and 2012. The World Standardized Rate (MSR) for men and women respectively was 4.9% and 2% in 1980 and 10.2% and 6.9% in 2012. This means an annual rate of change of 2.3 for men to 3.9 for women. Its diagnosis is often late, carried out in 50% of cases at stage 4, with limited treatment options, explaining its low survival rate at 5 years. Until 2011, gemcitabine remained the only validated standard with a median survival of 6 months. Many combinations with gemcitabine have been evaluated but have shown no significant survival advantage over Gemzar alone. The most promising results reported to date remain the combination of oxaliplatin, irinotecan and 5 fluoro-uracil (FOLFIRINOX), which became the standard metastatic first-line treatment thanks to the results of the phase III study, ACCORD11, randomizing gemcitabine to FFX with for the first time, a significant gain in median survival, progression-free survival and response rate in favor of the experimental arm of 6.8 months vs. 11.1 months respectively ([HR 0.57, 95 % IC, 0.45-0.7 3];p<0.001), 3.3vs6.4 ([HR 0.47, 95 % IC, 0.37- 0.59];p<0.001) et de 9.4 % vs 31.6 % ; p>0.001. In 2013, the combination gemcitabine nab-paclitaxel (GEMBRAX) showed, in a randomized phase III study, compared to gemcitabine, a significant gain in terms, median survival, survival without progression and response rate in favor of the experimental arm, respectively for gemcitabine vs GEMBRAX, 6.7 months vs 8.5 months ([HR 0.72, 95 % IC, 0.62-0.83];p<0.001) ; 3.7vs 5.5. ([HR 0.69, 95 % IC, 0.58- 0.82];p<0.001) et de 7 % vs 23% ; p>0.001. FOLFIRINOX and GEMBRAX, two chemotherapy protocols which have shown their effectiveness in the 1st metastatic line with a gain in terms of response rate, progression-free survival and median survival but with increased grade 3/4 toxicities, compared to treatment with gemcitabine. For FOLFIRINOX: a neutropenia rate of 45.7% vs 21% including 5.4% of febrile neutropenia vs 1.2, a rate of diarrhea of 12.7% vs 1.8% and peripheral neuropathies of 9% vs 0 For GEMBRAX neutropenia 38% VS 27% including 3% febrile neutropenia VS 1%, 6% diarrhea vs 1% and peripheral neuropathy 17% vs 1%: Given the high toxicities, only patients with favorable performance status are eligible to receive these regimens. The sponsor therefore considered a new concept of sequential GABRINOX treatment combining GEMBRAX followed by FOLFIRINOX, which should make it possible, by reducing toxicities, to increase the response rate and at the same time progression-free survival and median survival. The sponsor performed a phase 1/2 study evaluating this GABRINOX protocol with the main objective of determining the maximum tolerated dose and increasing the response rate. Phase 2 is encouraging with a disease control rate and an objective response rate of 84.2% and 64.9% respectively, progression-free survival at 10.5 months and overall survival at 15.1 months as well as a more favorable safety profile compared to non-sequential treatments (less neutropenia 34.5%, febrile neutropenia 3.5% and neurotoxicity 5.2%). These encouraging results led the investigator to propose a phase 2 study comparing the standard first-line treatment regimen FOLFIRINOX with the sequential regimen GABRINOX with the main objective of comparing efficacy in terms of objective response rate. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05065801
Study type Interventional
Source Institut du Cancer de Montpellier - Val d'Aurelle
Contact Jean-Pierre BLEUSE, MD
Phone 0467613102
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 2021
Completion date January 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04844970 - Anamorelin Study for Advanced Pancreatic Cancer Phase 2
Completed NCT01417000 - Safety and Efficacy of Combination Listeria/GVAX Immunotherapy in Pancreatic Cancer Phase 2
Active, not recruiting NCT02975141 - Afatinib and Gemcitabine/Nab-paclitaxel in Metastatic Pancreatic Cancer Phase 1
Active, not recruiting NCT00761345 - Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic Cancer Phase 1
Completed NCT00919282 - Gemcitabine (GFF) in Patients With Pancreatic Cancer Phase 2
Completed NCT01088815 - Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas Phase 2
Completed NCT04133155 - Retrospective Analysis of 2nd-line Nab-Paclitaxel + Gemcitabine After 1st-line FOLFIRINOX in Pancreatic Cancer
Recruiting NCT04612530 - PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab + CpG for Metastatic Pancreatic Cancer Phase 1
Recruiting NCT03602885 - EL CENTRO: Engaging Latinos in the Center of Cancer Treatment Options N/A
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Recruiting NCT03721744 - A Study of Napabucasin in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer Phase 3
Completed NCT03261947 - A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors Phase 2
Recruiting NCT05078775 - Medical Food for the Dietary Management of Metastatic Pancreatic Cancer N/A
Not yet recruiting NCT04901741 - Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer Phase 2
Terminated NCT01946646 - Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer Phase 1
Completed NCT01523457 - Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer Phase 2
Recruiting NCT00986661 - A Study to Assess PV-10 Chemoablation of Cancer of the Liver Phase 1
Terminated NCT00726037 - A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer Phase 2
Completed NCT00744640 - Gemcitabine, Oxaliplatin and Capecitabine for Advanced Pancreatic Carcinoma Phase 1/Phase 2
Recruiting NCT04589234 - Saltikva for Metastatic Pancreatic Cancer Phase 2