NCT00226746

Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer

A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: New York Presbyterian Brooklyn Methodist Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.

Detailed description

Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.

Conditions

• Carcinoma, Pancreatic Ductal

Interventions

Type	Name	Description
DRUG	Paclitaxel and gemcitabine	Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.

Timeline

• Start date: 2003-03-01
• Primary completion: 2010-06-01
• Completion: 2012-06-01
• First posted: 2005-09-27
• Last updated: 2020-09-18

Locations

1 site across 1 country: United States