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Trial record 12 of 857 for:    Pancreatic Cancer AND Progression-free survival

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

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ClinicalTrials.gov Identifier: NCT01459614
Recruitment Status : Active, not recruiting
First Posted : October 25, 2011
Results First Posted : January 23, 2019
Last Update Posted : May 31, 2019
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 (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV Days 4 and 11

Each cycle is 28 days (2 weeks Tx + 2 weeks off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV 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 (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV Days 4 and 11

Each cycle is 28 days (2 weeks Tx + 2 weeks off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV 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 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase from nadir in the sum of the longest diameter of target lesions, or a unequivocal progression in non-target lesions, or the appearance of new lesions
Time Frame 6 months
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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 (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV Days 4 and 11

Each cycle is 28 days (2 weeks Tx + 2 weeks off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV 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 Safety as Assessed by Number of Participants Experiencing Adverse Events (AEs) as Defined by CTCAE v4.0
Hide Description Number of participants with metastatic pancreatic cancer who received combination of GTX with cisplatin, experiencing AEs as defined by CTCAE v4.0
Time Frame Up to 18 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description Percentage of participants who have achieved partial (PR) or complete response (CR), or stable disease at 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months.
Time Frame Up to 18 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Time (in months) until disease progression or death, whichever occurs first.
Time Frame Up to 60 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time (in months) until death from any cause.
Time Frame Up to 60 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title PFS of an Expansion Cohort Testing an Alternative Schedule
Hide Description Time (in months) until disease progression or death, whichever occurs first.
Time Frame Up to 60 months
Outcome Measure Data Not Reported
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 9 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 (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV Days 4 and 11

Each cycle is 28 days (2 weeks Tx + 2 weeks off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.

Gemcitabine: IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11 Taxotere: IV on Days 4 and 11 Xeloda: orally, twice a day Days 1-14 Cisplatin: IV 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%) 
Show Serious Adverse Events 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
Show Other (Not Including Serious) Adverse Events 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     History of Changes
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: May 31, 2019