Clinical Trial: Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer
Brief 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 Summary: 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.
Sponsor: New York Methodist Hospital
Current Primary Outcome: One-year overall survival rate
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
- Occurrence of pathological response or shrinkage of the tumor (becomes resectable)
Original Secondary Outcome:
- Occurrence of grade 3 or higher toxicity in the gastro-intestinal or pulmonary.
- Occurrence of pathological response or shrinkage of the tumor (becomes resectable).
Information By: New York Methodist Hospital
Dates:
Date Received: September 23, 2005
Date Started: March 2003
Date Completion: December 2010
Last Updated: March 20, 2007
Last Verified: September 2006
