Trial Outcomes & Findings for A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer (NCT NCT00882310)

Last Updated: 2016-07-25

Results Overview

Safety of the GTX regimen in patients with resected pancreatic cancer, using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Data was not analyzed because original PI left institution before data analysis was completed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

At days 4, 11, and follow-up.

Results posted on

2016-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine, Docetaxel, Capecitabine GTX GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
Overall Study STARTED	37
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine, Docetaxel, Capecitabine GTX GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
Overall Study Screen Failure	10
Overall Study Never received treatment	1
Overall Study Death	6
Overall Study Progression of disease	4
Overall Study Adverse Event	1

Baseline Characteristics

A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine, Docetaxel, Capecitabine GTX n=37 Participants GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
Age, Customized 40-49	5 participants n=93 Participants
Age, Customized 50-59	8 participants n=93 Participants
Age, Customized 60-69	17 participants n=93 Participants
Age, Customized 70-79	7 participants n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	27 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants
Race (NIH/OMB) More than one race	4 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: At days 4, 11, and follow-up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 months (following completion of treatment), and then every 3 months for the first 2 years. After the first 2 year, annually.

Median recurrence free survival in patients with non-metastatic, resected pancreatic cancer treated with adjuvant GTX. Data was not analyzed because original PI left institution before data analysis was completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Prior to starting treatment, after 3 months of treatment, and at the end of study visit.

Quality of life score of patients treated with the adjuvant GTX regimen using, the FACT-Hep (Version 4), a sensitive measure of quality of life. Data was not analyzed because original PI left institution before data analysis was completed.

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine, Docetaxel, Capecitabine GTX

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine, Docetaxel, Capecitabine GTX n=26 participants at risk GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months. AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated).
General disorders Progression of Disease leading to death	19.2% 5/26 • Number of events 5 AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated).
General disorders Death of unknown reason	3.8% 1/26 • Number of events 1 AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated).

Other adverse events

Other adverse events
Measure	Gemcitabine, Docetaxel, Capecitabine GTX n=26 participants at risk GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months. AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated).
Vascular disorders Thrombosis/thrombus/embolism	3.8% 1/26 • Number of events 1 AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated).

Additional Information

Paul Oberstein, MD

Columbia University

Phone: 212-305-0592

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place