Conditions: Adenocarcinoma Pancreas
Keywords: NEOADJUVANT GEMCITABINE AND ABRAXANE CHEMOTHERAPY SURGERY RESECTABLE ADENOCARCINOMA OF THE PANCREAS
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will have screening tests to determine if he or she is eligible to participate in this study.

Detailed description:
If subjects are eligible and wish to enroll in the study, they will begin chemotherapy treatment with Gemcitabine and Abraxane. After subjects have received treatment with these drugs, they will have surgery. Subjects will also have post treatment and follow up evaluations. Subjects may have 2 cycles of treatment and each cycle is 28 days. All subjects will be followed every 3 months for 3 years after their initial registration.

Arms:
arm 1: All patients enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Treatment will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks.

Patients will move on to surgery, 4-8 weeks after chemotherapy treatment. Patients must be recovered from any adverse effects of the chemotherapy before proceeding with surgery.

As part of this study, tissue samples will be collect from each patient at the time of surgery for gene expression testing

Interventions: intervention 1: Surgery intervention 2: Genetic Expression intervention 3: Chemotherapy
Intervention descriptions: intervention 1: Subjects will then receive surgery at MUSC within 4-8 weeks following completion of chemotherapy intervention 2: Subjects will have genetic expression testing done on their tissue samples. intervention 3: Patients will receive gemcitabine at 1000 mg/m2 and abraxane at 125 mg/m2 intravenously on days 1, 8 and 15 of a 28 day cycle for 2 cycles

Protocol document: