NCT01783054

Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas

Pilot Study of Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery for Patients With Localized, Resectable Adenocarcinoma of the Pancreas

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma Pancreas

Interventions

Type	Name	Description
PROCEDURE	Surgery	Subjects will then receive surgery at MUSC within 4-8 weeks following completion of chemotherapy
GENETIC	Genetic Expression	Subjects will have genetic expression testing done on their tissue samples.
DRUG	Chemotherapy	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

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-10-01
• First posted: 2013-02-04
• Last updated: 2016-03-08
• Results posted: 2015-11-09

Locations

1 site across 1 country: United States