Perioperative Therapy for Resectable and Borderline-Resectable Pancreatic Adenocarcinoma With Molecular Correlates

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

December 30, 2016

Primary Completion Date

December 8, 2022

Study Completion Date

December 28, 2022

Conditions
Pancreatic CancerPancreatic AdenocarcinomaPancreas Ductal Adenocarcinoma
Interventions
DRUG

Nab paclitaxel

Nab-paclitaxel and gemcitabine, for R-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

DRUG

Gemcitabine

Nab-paclitaxel and gemcitabine, for BR-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.

Trial Locations (4)

10012

New York University, New York

80045

University of Colorado Cancer Center, Aurora

85259

Mayo Clinic Hospital, Scottsdale

85724

University of Arizona, Tucson

Sponsors
All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Criterium, Inc.

INDUSTRY

collaborator

University of Colorado, Denver

OTHER

lead

Academic Thoracic Oncology Medical Investigators Consortium

INDUSTRY