NCT01298011

Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer

A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Pancreatic Cancer Research Team · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are effective in treating patients with operable pancreatic cancer.

Detailed description

The best outcome for a patient diagnosed with pancreatic cancer is surgery. However many patients have recurrence of the cancer after successful surgery. The investigators are evaluating chemotherapy before surgery, which is a new approach. In this study, Abraxane and gemcitabine will be tested as treatment for people with operable pancreatic cancer to see if surgery can be successfully performed and if treatment will reduce cancer cells in the tumor at surgery. Abraxane is approved by the US FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Gemcitabine is approved by the FDA for first line treatment for patients with locally advanced or metastatic cancer of the pancreas.

Conditions

• Resectable Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine and Abraxane	3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-12-01
• Completion: 2015-05-01
• First posted: 2011-02-17
• Last updated: 2015-06-17

Locations

4 sites across 1 country: United States