Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|