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



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:April 21, 2015
End Date:April 26, 2018

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Nab-paclitaxel (Abraxane) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-label, Multi-center, Phase 2 Study (LAPACT).

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.

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.

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
We found this trial at
24
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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5301 McAuley Drive
Ann Arbor, Michigan 48106
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Atlanta, Georgia 30318
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Boston, Massachusetts
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Bronx, New York 10461
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Calgary, Alberta
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Charlotte, North Carolina 28211
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Detroit, MI
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Houston, Texas 77030
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Lake Success, New York 11042
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Morristown, New Jersey 07962
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New Haven, Connecticut 06520
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Orlando, Florida 32804
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Sacramento, California 95817
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San Diego, California 92037
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Scarborough, Maine 04074
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Washington, District of Columbia 20057
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Worcester, Massachusetts 01655
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