Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC) (LAPACT)
Pancreatic Neoplasms

About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreatic Neoplasms, Pancreatic Cancer, Locally advanced pacriatic cancer, nab-Paclitaxel, Abraxane, Gemcitabine, ABI-007
Eligibility Criteria
Inclusion Criteria:
- Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
No prior anticancer therapy for pancreatic cancer
•≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function
- Signed informed Consent
Exclusion Criteria:
- Active bacterial, viral, or fungal infection
- Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
- Subjects with sensory neuropathy, ascites, or plastic biliary stent.
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
- Women who are pregnant or breast feeding
Sites / Locations
- Mayo Clinic - Arizona
- UC Davis Cancer Center
- Scripps Clinic Torrey Pines
- Smilow Cancer Hospital At Yale-New Haven
- Georgetown University Medical Center Lombardi Cancer Center
- Florida Hospital Cancer Institute
- Piedmont Cancer Institute PC
- Cancer Treatment Centers of America - Southeastern Regional Medical Center
- ME Center for Cancer Medicine
- Tufts - New England Medical Center
- University of Massachusetts
- Saint Joseph Mercy Ann Arbor Hospital
- Karmanos Cancer Center Wayne State University
- Dartmouth Hitchcock Medical Center
- Regional Cancer Care Associates LLC
- Montefiore Einstein Cancer Center
- Roswell Park Cancer Institute
- Clinical Research Alliance
- State University of New York Upstate Medical Center
- Levine Cancer Institute
- Mark H Zangmeister Center
- Vanderbilt University Medical Center
- Houston Methodist Cancer Center
- Tom Baker Cancer Center
- Cross Cancer Institute
- British Columbia Cancer Agency
- CHUM Hôpital Saint-Luc
- McGill University
- Centre Regional de lutte contre le cancer Paul Papin
- CHRU Besancon
- Centre Hospitalier Belfort Montbeliard
- Hopital Beaujon
- Hopital Saint Antoine
- Hopital Haut Leveque
- Ospedale Sacro Cuore di Gesu FatebeneFratelli
- Azienda Ospedaliera Universitaria San Martino
- Policlinico Universitario Campus Biomedico Di Roma
- Hospital Universitario a Coruna
- ICO-Hospital Germans Trias i Pujol
- Hospital Clinico San Carlos
- Hospital Universitario Marques de Valdecilla
- Hospital Miguel Servet
Arms of the Study
Arm 1
Experimental
nab-Paclitaxel plus Gemcitabine
nab-Paclitaxel 125 mg/m2 intravenous (IV) infusion over approximately 30 to 45 minutes on Days 1, 8, and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle Subjects who complete 6 cycles of nab-paclitaxel and gemcitabine without disease progression or unacceptable toxicities, the Investigator will then determine the best option for the subject. Continuation of nab-paclitaxel and gemcitabine therapy to disease progression or unacceptable toxicity OR Chemoradiation therapy consisting of the concurrent use of capecitabine or gemcitabine with radiation according to institutional practice OR Surgical intervention