NCT01964287

First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma.

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	GEMBRAX
DRUG	FOLFIRINOX

Timeline

• Start date: 2013-09-24
• Primary completion: 2016-12-22
• Completion: 2020-12-30
• First posted: 2013-10-17
• Last updated: 2020-12-31

Locations

1 site across 1 country: France