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Trial record 69 of 1598 for:    Pancreatic Cancer | United States

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
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Columbia University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Intervention Drug: Gemcitabine, Docetaxel, Capecitabine
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemzar, Taxotere, Xeloda
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Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

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.

Period Title: Overall Study
Started 46
Completed 33
Not Completed 13
Reason Not Completed
Screen failure             1
Withdrawal by Subject             1
Death             4
Adverse Event             1
Physician Decision             1
Other             5
Arm/Group Title Gemzar, Taxotere, Xeloda
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Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

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.

Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
Between 30 and 39 years 2
Between 40 and 49 years 4
Between 50 and 59 years 16
Between 60 and 69 years 20
Between 70 and 79 years 3
Unknown 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
18
  39.1%
Male
28
  60.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Hispanic or Latino
3
   6.5%
Not Hispanic or Latino
41
  89.1%
Unknown or Not Reported
2
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.3%
White
40
  87.0%
More than one race
2
   4.3%
Unknown or Not Reported
2
   4.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
1.Primary Outcome
Title To Determine Response Rate to the GTX Regimen in Patients With Pancreatic Cancer
Hide Description Data was not analyzed because original PI left institution before data analysis was completed.
Time Frame 10 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemzar, Taxotere, Xeloda
Hide Arm/Group Description:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Determine Overall and One Year Survival Rates
Hide Description Data was not analyzed because original PI left institution before data analysis was completed.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemzar, Taxotere, Xeloda
Hide Arm/Group Description:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Toxicity Assessment
Hide Description Data was not analyzed because original PI left institution before data analysis was completed.
Time Frame Every month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemzar, Taxotere, Xeloda
Hide Arm/Group Description:

Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
 
Arm/Group Title Gemzar, Taxotere, Xeloda
Hide Arm/Group Description

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

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.

All-Cause Mortality
Gemzar, Taxotere, Xeloda
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemzar, Taxotere, Xeloda
Affected / at Risk (%) # Events
Total   16/45 (35.56%)    
Blood and lymphatic system disorders   
Pancytopenia and diarrhea * [1]  1/45 (2.22%)  1
Leukopenia and hypotension * [1]  1/45 (2.22%)  1
Thrombocytopenia * [1]  1/45 (2.22%)  1
Cardiac disorders   
Heart attack leading to death *  1/45 (2.22%)  1
Eye disorders   
Temporary loss of vision in the right eye * [1]  1/45 (2.22%)  1
Gastrointestinal disorders   
Small bowel * [1]  1/45 (2.22%)  1
Mucositis * [1]  1/45 (2.22%)  1
General disorders   
Alveolitis leading to death *  1/45 (2.22%)  1
Leg edema * [1]  1/45 (2.22%)  1
Fever and chills * [1]  2/45 (4.44%)  2
Headache * [1]  1/45 (2.22%)  1
Shortness of breath * [1]  1/45 (2.22%)  1
Constipation, nausea and vomiting * [1]  1/45 (2.22%)  1
Death due to unknown reason *  2/45 (4.44%)  2
Hepatobiliary disorders   
Hyponatremia and elevated liver enzymes * [2]  1/45 (2.22%)  1
Infections and infestations   
Fever and infection * [1]  1/45 (2.22%)  1
Sepsis and neutropenia * [1]  1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders   
Lower abdominal and back pain * [1]  1/45 (2.22%)  1
Surgical and medical procedures   
Surgery *  1/45 (2.22%)  1
Port-a-cath *  1/45 (2.22%)  1
Vascular disorders   
Blood clot * [1]  1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Hospitalized
[2]
Hospitalized for this event. Also suffered from dilation of small bowel with pneumatosis.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gemzar, Taxotere, Xeloda
Affected / at Risk (%) # Events
Total   3/45 (6.67%)    
Gastrointestinal disorders   
Mucositis *  1/45 (2.22%)  1
General disorders   
Vomiting *  1/45 (2.22%)  1
Vascular disorders   
Syncope *  1/45 (2.22%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul Oberstein
Organization: Columbia University
Phone: 212-305-0592
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00996333     History of Changes
Other Study ID Numbers: AAAB8628
First Submitted: October 14, 2009
First Posted: October 16, 2009
Results First Submitted: April 27, 2016
Results First Posted: June 22, 2016
Last Update Posted: July 25, 2016