Trial Outcomes & Findings for Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer (NCT NCT01459614)

Last Updated: 2021-05-19

Results Overview

PFS is defined as the percentage of patients with disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

6 months

Results posted on

2021-05-19

Participant Flow

44 patients were consented and screened. Of these, 5 were screen failures and 39 were eligible and assigned to receive treatment.

Participant milestones

Participant milestones
Measure	Primary Cohort (21 Day Cycle) Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Overall Study STARTED	29	10
Overall Study COMPLETED	28	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Primary Cohort (21 Day Cycle) Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Overall Study Adverse Event	1	0

Baseline Characteristics

Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Cohort (21 Day Cycle) n=29 Participants Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) n=10 Participants Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Total n=39 Participants Total of all reporting groups
Age, Continuous	59 years n=93 Participants	67 years n=4 Participants	62 years n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	2 Participants n=4 Participants	15 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	8 Participants n=4 Participants	24 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=93 Participants	8 Participants n=4 Participants	36 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	29 participants n=93 Participants	10 participants n=4 Participants	39 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: One patient was consented and enrolled, but was not considered evaluable per protocol, as he came off study prior to completing a cycle of treatment for reasons other than disease progression or death.

Outcome measures

Outcome measures
Measure	Primary Cohort (21 Day Cycle) n=28 Participants Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) n=10 Participants Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months	78.6 percentage of participants Interval 59.0 to 92.0	30 percentage of participants Interval 7.0 to 65.0

SECONDARY outcome

Timeframe: Up to 23 months

When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months.

Outcome measures

Outcome measures
Measure	Primary Cohort (21 Day Cycle) n=29 Participants Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) n=10 Participants Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity	26 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 22 months

Population: Outcome was assessed for the Primary Cohort only per protocol. One patient was consented and enrolled, but was not considered evaluable per protocol, as he came off study prior to completing a cycle of treatment for reasons other than disease progression or death.

DCR is defined as the percentage of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Outcome measures

Outcome measures
Measure	Primary Cohort (21 Day Cycle) n=28 Participants Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Disease Control Rate (DCR)	89 Percentage of Participants Interval 72.0 to 98.0	—

SECONDARY outcome

Timeframe: Up to 21 months

PFS is defined as the the number of months from the date of first dose to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause . Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Primary Cohort (21 Day Cycle) n=28 Participants Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) n=10 Participants Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Progression-free Survival (PFS)	8.4 Months Interval 6.58 to 13.72	4.1 Months Interval 3.74 to NA means that the upper bound confidence interval was not reached because the sample size was too small to estimate upper limit.

SECONDARY outcome

Timeframe: Up to 28 months

OS (in months) will be measured from date of first dose until death (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.

Outcome measures

Outcome measures
Measure	Primary Cohort (21 Day Cycle) n=28 Participants Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Overall Survival (OS)	13.42 Months Interval 10.48 to 20.13	—

Adverse Events

Primary Cohort (21 Day Cycle)

Serious events: 5 serious events

Other events: 29 other events

Deaths: 24 deaths

Expansion Cohort (28 Day Cycle)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Primary Cohort (21 Day Cycle) n=29 participants at risk Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.	Expansion Cohort (28 Day Cycle) n=10 participants at risk Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Blood and lymphatic system disorders febrile neutropenia	10.3% 3/29 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.	0.00% 0/10 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.
Gastrointestinal disorders mucositis	3.4% 1/29 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.	0.00% 0/10 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.
Gastrointestinal disorders nausea	3.4% 1/29 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.	0.00% 0/10 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.
Investigations neutrophil count decreased	3.4% 1/29 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.	0.00% 0/10 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.
Gastrointestinal disorders vomiting	3.4% 1/29 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.	0.00% 0/10 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.
Nervous system disorders intracranial hemorrhage	0.00% 0/29 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.	10.0% 1/10 • AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months. AEs collected during protocol-specified visits, labs, and quality of life surveys.

Other adverse events

Additional Information

Dr. Dung Le

Sidney Kimmel Comprehensive Cancer Center

Phone: 443-287-0002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place