The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes
Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes
Day 28 according to the dose levels stablished in Phase I
Spanish Cooperative for Digestive Tumour Therapy (TTD)
Madrid, Spain
Dose-limiting toxicity for the AG-mFOLFOX combination
Primary outcome phase I.
Time frame: 12 weeks
Rate of overall survival al 12 months
Primary outcome phase II
Time frame: 12 weeks
Rate of overall survival at 6 months
Time frame: 54 months
Rate of overall survival at 24 months
Time frame: 54 months
Time to tumor progression
Time frame: 54 months
Progression free survival
Time frame: 54 months
Overall Survival
Time frame: 54 months
Objective radiographic response
Secondary outcome Phase I and Phase II
Time frame: 54 months
CA 19-9 biomarker response
Time frame: 54 months
Safety profile of this combination (AG-mFOLFOX) using NCI-CTCAE v.4 criteria
Secondary outcome Phase I and Phase II
Time frame: 54 months
To assess the Quality of Life of the patients through the EORTC QLQ-C30/PAN26 and EORTC QLQ-CIPN20 questionnaires
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Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I
Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I
Secondary outcome Phase I and Phase II
Time frame: 54 months