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


Title Nab-Paclitaxel (Abraxane®) Plus Gemcitabine In Subjects With Locally Advanced Pancreatic Cancer (LAPC): An International, Open-Label, Multi-Center, Phase 2 Study (LAPACT)
Therapeutic Area Pancreatic Cancer
Principal Investigator Wasif Saif, MD
Min Age 18 Years
Gender Both
Contact Leanne Ianniello
617-636-2883
More Information https://clinicaltrials.gov/ct2/show/NCT02301143

Overview

This clinical study is in subjects 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.

Study Details

Inclusion Criteria

  • Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
  • No prior anticancer therapy for pancreatic cancer

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

Study Requirements

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.