Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
Conditions
Pancreatic Neoplasms
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Pancreatic Neoplasms, Pancreatic Cancer, Locally advanced pacriatic cancer, nab-Paclitaxel, Abraxane, Gemcitabine, ABI-007
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: nab-Paclitaxel Type: Drug
Name: Gemcitabine Type: Drug
Name: Chemoradiation Type: Drug
Name: Capecitabine Type: Drug
Name: Surgery Type: Procedure
Overall Status
Recruiting
Summary
This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.
Detailed Description
This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. All subjects will be treated with nab-paclitaxel plus gemcitabine for 6 cycles followed by an Investigator's Choice of continuation of treatment with nab-paclitaxel plus gemcitabine, chemoradiation therapy, or surgery.

Safety assessments by laboratory testing and physical exams will be conducted through-out the study.

Efficacy assessments by physical exam will be preformed through-out the study and tumor imaging will be conducted approximately every 2 months.

Subjects will be considered active study participants from enrollment up to, but not including, survival follow-up period.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Status: Recruiting
Piedmont Cancer Institute P.C .
Atlanta, Georgia, United States
Status: Recruiting
Cancer Treatment Centers of America
Newnan, Georgia, United States
Status: Recruiting
New England Cancer Specialists
Scarborough, Maine, United States
Status: Recruiting
Tufts Medical Center
Boston, Massachusetts, United States
Status: Recruiting
University of Massachusetts
Worcester, Massachusetts, United States
Status: Recruiting
Saint Joseph Mercy Ann Arbor Hospital
Ann Arbor, Michigan, United States
Status: Recruiting
Karmanos Cancer Institute
Detroit, Michigan, United States
Status: Recruiting
Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Status: Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Clinical Research Alliance
New York, New York, United States
Status: Recruiting
The Mark H Zangmeister Center
Columbus, Ohio, United States
Status: Recruiting
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Cross Cancer Institute
Edmonton, Alberta, Canada
Status: Recruiting
IRCCS Azienda Ospedaliera Universitaria San Martino-IST
Genova, Italy
Status: Recruiting
Policlinico Universitario Campus Biomedico Di Roma
Roma Lecco, Italy
Status: Recruiting
Policlinico Universitario Campus Biomedico Di Roma
Roma, Italy
Status: Recruiting
Complejo Universitario Hospitalario A Coruña
A Coruña, Spain
Status: Recruiting
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain
Status: Recruiting
Hospital Clinico San Carlos
Madrid, Spain
Status: Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Spain
Status: Recruiting
Hospital Universitario Miguel Servet
Zaragoza, Spain
Status: Recruiting
Start Date
December 2014
Completion Date
June 2018
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page