Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
|ClinicalTrials.gov Identifier: NCT00996333|
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : June 22, 2016
Last Update Posted : July 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: Gemcitabine, Docetaxel, Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) With Gemzar, Taxotere and Xeloda (GTX)|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Gemzar, Taxotere, Xeloda
Gemcitabine, Docetaxel, Capecitabine:
Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days
Drug: Gemcitabine, Docetaxel, Capecitabine
1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11
This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles.
- To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer [ Time Frame: 10 weeks ]Data was not analyzed because original PI left institution before data analysis was completed.
- Determine Overall and One Year Survival Rates [ Time Frame: One year ]Data was not analyzed because original PI left institution before data analysis was completed.
- Toxicity Assessment [ Time Frame: Every month ]Data was not analyzed because original PI left institution before data analysis was completed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996333
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert L Fine, MD||Columbia University|