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First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma. — GABRINOX  

Metastatic Pancreatic Adenocarcinoma Clinical Trial

Official title:
Phase I-II Trial of Gemcitabine Plus Nab-paclitaxel (GemBrax) Followed by Folfirinox as First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.

Clinical Trial Summary

Based on conventional chemotherapy approach, data have indicated that the Folfirinox regimen is more effective and tolerate than the treatment by Gemcitabine alone in patients with metastatic pancreatic adenocarcinoma. A recent study combining gemcitabine and nab paclitaxel improve the objective response rate. Primary objective of this study is to identify the maximun tolerated dose and the recommended phase II dose of first line treatment combining gemcitabine plus nab-paclitaxel followed by folfirinox in metastatic pancreatic adenocarcinoma.

Clinical Trial Description

Estimated enrollment: Phase I: 60 Phase II: 53 Study start Date: August 2013 Estimated study completion date: March 2016 Treatment: Gembrax: albumin-bound paclitaxel over 30 minutes IV followed by Gemcitabine 10mg/m²/min IV on day 1, 8 and 15 followed by 2 weeks of rest Folfirinox: Oxaliplatin IV associated with LeucovorinIV. After the end of leucovorin administration, bolus injection of 5FU and subsequent continuous 5FU 46-hour infusion at day 29 and 43. Day 1=Day 57 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01964287
Study type Interventional
Source Institut du Cancer de Montpellier - Val d'Aurelle
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 24, 2013
Completion date December 30, 2020
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