Trial Outcomes & Findings for Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB) (NCT NCT00996333)

NCT ID: NCT00996333

Last Updated: 2016-07-25

Results Overview

Data was not analyzed because original PI left institution before data analysis was completed.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2016-07-25

Participant Flow

Participant milestones

Measure	Gemzar, Taxotere, Xeloda 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 Study STARTED	46
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Gemzar, Taxotere, Xeloda 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 Study Screen failure	1
Overall Study Withdrawal by Subject	1
Overall Study Death	4
Overall Study Adverse Event	1
Overall Study Physician Decision	1
Overall Study Other	5

Baseline Characteristics

Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)

Baseline characteristics by cohort

Measure	Gemzar, Taxotere, Xeloda n=46 Participants 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.
Age, Customized Between 30 and 39 years	2 participants n=5 Participants
Age, Customized Between 40 and 49 years	4 participants n=5 Participants
Age, Customized Between 50 and 59 years	16 participants n=5 Participants
Age, Customized Between 60 and 69 years	20 participants n=5 Participants
Age, Customized Between 70 and 79 years	3 participants n=5 Participants
Age, Customized Unknown	1 participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Data was not analyzed because original PI left institution before data analysis was completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Data was not analyzed because original PI left institution before data analysis was completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every month

Data was not analyzed because original PI left institution before data analysis was completed.

Outcome measures

Outcome data not reported

Adverse Events

Gemzar, Taxotere, Xeloda

Serious events: 16 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Gemzar, Taxotere, Xeloda n=45 participants at risk 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.
Surgical and medical procedures Port-a-cath	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
General disorders Shortness of breath	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Vascular disorders Blood clot	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Surgical and medical procedures Surgery	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
General disorders Alveolitis leading to death	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
General disorders Leg edema	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
General disorders Fever and chills	4.4% 2/45 • Number of events 2 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Infections and infestations Fever and infection	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
General disorders Headache	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Eye disorders Temporary loss of vision in the right eye	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Gastrointestinal disorders Small bowel	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Blood and lymphatic system disorders Pancytopenia and diarrhea	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Musculoskeletal and connective tissue disorders Lower abdominal and back pain	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Blood and lymphatic system disorders Leukopenia and hypotension	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Infections and infestations Sepsis and neutropenia	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Gastrointestinal disorders Mucositis	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Blood and lymphatic system disorders Thrombocytopenia	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
General disorders Constipation, nausea and vomiting	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Hepatobiliary disorders Hyponatremia and elevated liver enzymes	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
General disorders Death due to unknown reason	4.4% 2/45 • Number of events 2 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Cardiac disorders Heart attack leading to death	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).

Other adverse events

Measure	Gemzar, Taxotere, Xeloda n=45 participants at risk 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.
General disorders Vomiting	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Vascular disorders Syncope	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).
Gastrointestinal disorders Mucositis	2.2% 1/45 • Number of events 1 AE data was only collected on 45 subjects (out of 46 subjects, 1 was a screen failure).

Additional Information

Paul Oberstein

Columbia University

Phone: 212-305-0592

Email: po2178@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place