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

Completed · Phase 2

Conditions studied: Pancreatic Neoplasms

In brief

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.

Key facts

Study ID

NCT02301143

Run by

Celgene

People needed

107

Starts

2015-04-21

Expected to finish

2018-04-26

Last updated by the study team

2019-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic - Arizona — Scottsdale, Arizona, United States
• UC Davis Cancer Center — Sacramento, California, United States
• Scripps Clinic Torrey Pines — San Diego, California, United States
• Smilow Cancer Hospital At Yale-New Haven — New Haven, Connecticut, United States
• Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Piedmont Cancer Institute PC — Atlanta, Georgia, United States
• Cancer Treatment Centers of America - Southeastern Regional Medical Center — Newnan, Georgia, United States
• ME Center for Cancer Medicine — Scarborough, Maine, United States
• Tufts - New England Medical Center — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• Saint Joseph Mercy Ann Arbor Hospital — Ann Arbor, Michigan, United States
• Karmanos Cancer Center Wayne State University — Detroit, Michigan, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Regional Cancer Care Associates LLC — Morristown, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Clinical Research Alliance — Lake Success, New York, United States
• State University of New York Upstate Medical Center — Syracuse, New York, United States
• Montefiore Einstein Cancer Center — The Bronx, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Mark H Zangmeister Center — Columbus, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Houston Methodist Cancer Center — Houston, Texas, United States
• Tom Baker Cancer Center — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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