NCT00833859

Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery

A Phase 2 Study of GTX-SRS: Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery for Borderline Resectable Pancreatic Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at the patient's tumor followed by more chemotherapy can increase the chances that the patient's pancreatic tumor can be removed completely.

Detailed description

* Cycle 1 and 2: * Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m\^2 intravenous piggy back (IVPB) over 30 min * Days 4, 11 and 25, 32 ....docetaxel 30 mg/m\^2 IVPB over 1 hour * Days 1-14 and 22-35 ....capecitabine 750 mg/m\^2 oral twice daily * Each cycle is 21 days long * SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume * Cycle 3 and 4: * Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m\^2 IVPB over 30 min * Days 54, 61 and 75, 82 ....docetaxel 30 mg/m\^2 IVPB over 1 hour * Days 51-64 ....capecitabine 750 mg/m\^2 oral twice daily * Each cycle is 21 days long * Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or central pancreatectomy with or without vein resection and reconstruction as appropriate.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	GTX (gemcitabine, docetaxel and capecitabine)	GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14
RADIATION	stereotactic body radiation therapy	stereotactic body radiation therapy (SBRT) 25

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-02-02
• Last updated: 2017-10-09
• Results posted: 2011-05-26

Locations

1 site across 1 country: United States