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Trial record 12 of 907 for:    Pancreatic Cancer AND Progression-free survival

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01459614
Recruitment Status : Completed
First Posted : October 25, 2011
Results First Posted : January 23, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Swim Across America
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Gemcitabine
Drug: Taxotere
Drug: Xeloda
Drug: Cisplatin
Enrollment 44
Recruitment Details  
Pre-assignment Details 44 patients were consented and screened. Of these, 5 were screen failures and 39 were eligible and assigned to receive treatment.
Arm/Group Title Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Hide Arm/Group Description Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11. Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Period Title: Overall Study
Started 29 10
Completed 28 10
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle) Total
Hide Arm/Group Description Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11. 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 of all reporting groups
Overall Number of Baseline Participants 29 10 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants 10 participants 39 participants
59
(43 to 75)
67
(49 to 75)
62
(43 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 10 participants 39 participants
Female
13
  44.8%
2
  20.0%
15
  38.5%
Male
16
  55.2%
8
  80.0%
24
  61.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 10 participants 39 participants
Hispanic or Latino
1
   3.4%
2
  20.0%
3
   7.7%
Not Hispanic or Latino
28
  96.6%
8
  80.0%
36
  92.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 10 participants 39 participants
29 10 39
1.Primary Outcome
Title Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Hide Arm/Group Description:
Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
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 Number of Participants Analyzed 28 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.6
(59 to 92)
30
(7 to 65)
2.Secondary Outcome
Title Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity
Hide Description 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.
Time Frame Up to 23 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Hide Arm/Group Description:
Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
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 Number of Participants Analyzed 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
26
  89.7%
5
  50.0%
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description 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.
Time Frame Up to 22 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Cohort (21 Day Cycle)
Hide Arm/Group Description:
Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Overall Number of Participants Analyzed 28
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
89
(72 to 98)
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description 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.
Time Frame Up to 21 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Hide Arm/Group Description:
Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
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 Number of Participants Analyzed 28 10
Median (95% Confidence Interval)
Unit of Measure: Months
8.4
(6.58 to 13.72)
4.1 [1] 
(3.74 to NA)
[1]
NA means that the upper bound confidence interval was not reached.
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
Time Frame Up to 28 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Primary Cohort (21 Day Cycle)
Hide Arm/Group Description:
Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
Overall Number of Participants Analyzed 28
Median (95% Confidence Interval)
Unit of Measure: Months
13.42
(10.48 to 20.13)
Time Frame 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.
Adverse Event Reporting Description AEs collected during protocol-specified visits, labs, and quality of life surveys.
 
Arm/Group Title Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Hide Arm/Group Description Each cycle is 21 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11. Each cycle is 28 days. Xeloda (PO BID) given days 1-14, Gemcitabine (IV), Taxotere (IV), and Cisplatin (IV) given days 4 and 11.
All-Cause Mortality
Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Affected / at Risk (%) Affected / at Risk (%)
Total   24/29 (82.76%)   7/10 (70.00%) 
Hide Serious Adverse Events
Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/29 (17.24%)   1/10 (10.00%) 
Blood and lymphatic system disorders     
febrile neutropenia  1  3/29 (10.34%)  0/10 (0.00%) 
Gastrointestinal disorders     
mucositis  1  1/29 (3.45%)  0/10 (0.00%) 
nausea  1  1/29 (3.45%)  0/10 (0.00%) 
vomiting  1  1/29 (3.45%)  0/10 (0.00%) 
Investigations     
neutrophil count decreased  1  1/29 (3.45%)  0/10 (0.00%) 
Nervous system disorders     
intracranial hemorrhage  1  0/29 (0.00%)  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Primary Cohort (21 Day Cycle) Expansion Cohort (28 Day Cycle)
Affected / at Risk (%) Affected / at Risk (%)
Total   29/29 (100.00%)   10/10 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  19/29 (65.52%)  3/10 (30.00%) 
leukopenia  1  2/29 (6.90%)  0/10 (0.00%) 
Lymphopenia  1  10/29 (34.48%)  3/10 (30.00%) 
Neutropenia  1  21/29 (72.41%)  3/10 (30.00%) 
Thrombocytopenia  1  9/29 (31.03%)  4/10 (40.00%) 
Ear and labyrinth disorders     
Ear pain  1  2/29 (6.90%)  0/10 (0.00%) 
Hearing impairment  1  0/29 (0.00%)  1/10 (10.00%) 
Tinnitus  1  0/29 (0.00%)  1/10 (10.00%) 
Eye disorders     
Photophobia  1  0/29 (0.00%)  1/10 (10.00%) 
Blurred vision  1  3/29 (10.34%)  0/10 (0.00%) 
Vision Changes  1  3/29 (10.34%)  0/10 (0.00%) 
Watering eyes  1  4/29 (13.79%)  0/10 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  0/29 (0.00%)  1/10 (10.00%) 
Anorexia  1  4/29 (13.79%)  2/10 (20.00%) 
Bloating  1  0/29 (0.00%)  1/10 (10.00%) 
Colitis  1  0/29 (0.00%)  1/10 (10.00%) 
Constipation  1  3/29 (10.34%)  0/10 (0.00%) 
Diarrhea  1  15/29 (51.72%)  7/10 (70.00%) 
Dry Mouth  1  2/29 (6.90%)  0/10 (0.00%) 
Flatulence  1  3/29 (10.34%)  1/10 (10.00%) 
Hiccups  1  0/29 (0.00%)  1/10 (10.00%) 
Indigestion or GERD  1  3/29 (10.34%)  2/10 (20.00%) 
Mouth sores  1  4/29 (13.79%)  0/10 (0.00%) 
Nausea  1  16/29 (55.17%)  3/10 (30.00%) 
Vomiting  1  10/29 (34.48%)  6/10 (60.00%) 
Weight loss  1  3/29 (10.34%)  0/10 (0.00%) 
General disorders     
Chest pain  1  0/29 (0.00%)  1/10 (10.00%) 
Edema  1  2/29 (6.90%)  3/10 (30.00%) 
Fatigue  1  12/29 (41.38%)  2/10 (20.00%) 
Fever  1  4/29 (13.79%)  1/10 (10.00%) 
Infusion reaction  1  0/29 (0.00%)  1/10 (10.00%) 
Night sweats  1  0/29 (0.00%)  1/10 (10.00%) 
Infections and infestations     
Thrush  1  3/29 (10.34%)  4/10 (40.00%) 
Investigations     
ALT, increased  1  3/29 (10.34%)  0/10 (0.00%) 
AST, increased  1  1/29 (3.45%)  1/10 (10.00%) 
Bilirubin, increased  1  0/29 (0.00%)  1/10 (10.00%) 
Creatinine, increased  1  2/29 (6.90%)  2/10 (20.00%) 
Metabolism and nutrition disorders     
Dehydration  1  2/29 (6.90%)  0/10 (0.00%) 
Hypokalemia  1  4/29 (13.79%)  0/10 (0.00%) 
Hypomagnesemia  1  16/29 (55.17%)  4/10 (40.00%) 
Nervous system disorders     
Dizziness  1  5/29 (17.24%)  0/10 (0.00%) 
Dysgeusia  1  17/29 (58.62%)  3/10 (30.00%) 
Neuropathy  1  12/29 (41.38%)  3/10 (30.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  4/29 (13.79%)  2/10 (20.00%) 
Rhinitis  1  3/29 (10.34%)  0/10 (0.00%) 
Smell Sensitivity  1  2/29 (6.90%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  25/29 (86.21%)  8/10 (80.00%) 
Blisters  1  2/29 (6.90%)  0/10 (0.00%) 
Dry skin  1  4/29 (13.79%)  2/10 (20.00%) 
Nail Changes  1  10/29 (34.48%)  3/10 (30.00%) 
Rash  1  0/29 (0.00%)  1/10 (10.00%) 
Vascular disorders     
Hypotension  1  0/29 (0.00%)  1/10 (10.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dung Le
Organization: Sidney Kimmel Comprehensive Cancer Center
Phone: 443-287-0002
EMail: dle2@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01459614    
Other Study ID Numbers: J11125
NA_00066595 ( Other Identifier: JHM IRB )
Swim Across America Laboratory ( Other Identifier: Swim Across America )
First Submitted: October 24, 2011
First Posted: October 25, 2011
Results First Submitted: January 16, 2019
Results First Posted: January 23, 2019
Last Update Posted: March 13, 2020