Spots Global Cancer Trial Database for Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
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Trial Identification
Brief Title: Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
Official Title: Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).
Study ID: NCT02301143
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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
Montefiore Einstein Cancer Center, Bronx, New York, 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
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
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
CHUM Hôpital Saint-Luc, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Centre Regional de lutte contre le cancer Paul Papin, Angers, , France
CHRU Besancon, Besançon, , France
Centre Hospitalier Belfort Montbeliard, Besançon, , France
Hopital Beaujon, Clichy cedex, , France
Hopital Saint Antoine, Paris, , France
Hopital Haut Leveque, Pessac Cedex, , France
Ospedale Sacro Cuore di Gesu FatebeneFratelli, Benevento, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Policlinico Universitario Campus Biomedico Di Roma, Roma, , Italy
Hospital Universitario a Coruna, A Coruna, , Spain
ICO-Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Teng Jin Ong, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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