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Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00696696
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : December 21, 2011
Last Update Posted : June 30, 2016
Sponsor:
Collaborators:
Bayer
OSI Pharmaceuticals
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Gemcitabine
Drug: Erlotinib
Drug: Sorafenib
Enrollment 45
Recruitment Details The study enrolled 45 patients from September 2007 to May 2010 at New York University Medical center and affiliated hospital, New York, NY and Desert Regional Medical center, Palm Springs, CA.
Pre-assignment Details One patient was enrolled but then withdrew consent before treatment.
Arm/Group Title Combination GES
Hide Arm/Group Description Combination of Gemcitabine, Erlotinib, and Sorafenib
Period Title: Overall Study
Started 44
Completed 26 [1]
Not Completed 18
Reason Not Completed
Adverse Event             5
Withdrawal by Subject             8
Physician Decision             2
Death             3
[1]
number of patients off treatment due to progression of disease only
Arm/Group Title Combination GES
Hide Arm/Group Description Combination of Gemcitabine, Erlotinib, and Sorafenib
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
  51.1%
>=65 years
22
  48.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
64
(45 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
13
  28.9%
Male
32
  71.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
1.Primary Outcome
Title 4-month Progression Free Survival (PFS) Rate
Hide Description The PFS rate at 4 months is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment. Disease progression is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al, 2000). Radiological measurements to determine progression is performed every 2 cycles.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the number of patients treated.
Arm/Group Title Combination GES
Hide Arm/Group Description:
Combination of Gemcitabine, Erlotinib, and Sorafenib
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of patients
49
2.Secondary Outcome
Title Objective Response Rate
Hide Description The response rate is the percentage of the patients who have a complete response or partial response based on RECIST from the start of the treatment. The response is evaluated every 2 cycles by radiologic methods (e.g., computer tomography (CT)).
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the number of patients evaluable for response. The evaluable patients were those patients who received any treatment and had first response assessment followed by at least one confirmatory scan.
Arm/Group Title Combination GES
Hide Arm/Group Description:
Combination of Gemcitabine, Erlotinib, and Sorafenib
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of patients
7
3.Secondary Outcome
Title Median Overall Survival (mOS)
Hide Description Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Based on the number of patients treated.
Arm/Group Title Combination GES
Hide Arm/Group Description:
Combination of Gemcitabine, Erlotinib, and Sorafenib
Overall Number of Participants Analyzed 44
Median (95% Confidence Interval)
Unit of Measure: days
195
(144 to 290)
Time Frame up to 1 year (treatment period plus 30 days after the treatment)
Adverse Event Reporting Description All the events were included regardless they were related or not related to the treatment drugs.
 
Arm/Group Title Combination GES
Hide Arm/Group Description Combination of Gemcitabine, Erlotinib, and Sorafenib
All-Cause Mortality
Combination GES
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Combination GES
Affected / at Risk (%) # Events
Total   14/44 (31.82%)    
Cardiac disorders   
cardiac general  1  1/44 (2.27%)  1
hypotension  1  1/44 (2.27%)  1
Gastrointestinal disorders   
anorexia  1  1/44 (2.27%)  1
diarrhea  1  2/44 (4.55%)  2
hemorrhage (GI)  1  1/44 (2.27%)  1
nausea  1  1/44 (2.27%)  1
obstruction  1  1/44 (2.27%)  2
perforation  1  2/44 (4.55%)  2
vomiting  1  1/44 (2.27%)  1
General disorders   
constitutional symptoms  1  2/44 (4.55%)  4
fever  1  1/44 (2.27%)  1
Infections and infestations   
febrile neutropenia  1  1/44 (2.27%)  1
infection with normal Anc or grade 1 or 2 neutropenia  1  1/44 (2.27%)  1
infection with unknown Anc  1  1/44 (2.27%)  2
Investigations   
AST, SGOT  1  1/44 (2.27%)  1
bilirubin  1  1/44 (2.27%)  1
Nervous system disorders   
confusion  1  1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Combination GES
Affected / at Risk (%) # Events
Total   36/44 (81.82%)    
Blood and lymphatic system disorders   
blood/bone marrow-other  1  10/44 (22.73%)  25
edema: limb  1  6/44 (13.64%)  11
hemoglobin  1  14/44 (31.82%)  25
leukocytes  1  10/44 (22.73%)  35
lymphopenia  1  8/44 (18.18%)  27
neutrophils/granulocytes  1  6/44 (13.64%)  18
Cardiac disorders   
hypertension  1  2/44 (4.55%)  2
Eye disorders   
vision-blurred vision  1  2/44 (4.55%)  2
Gastrointestinal disorders   
anorexia  1  13/44 (29.55%)  21
constipation  1  4/44 (9.09%)  5
diarrhea  1  25/44 (56.82%)  54
distension/bloating, abdominal  1  12/44 (27.27%)  22
flatulence  1  5/44 (11.36%)  12
hemorrhage (GI)  1  4/44 (9.09%)  5
hemorrhoid  1  2/44 (4.55%)  3
mucositis/stomatitis (functional/symptomatic)  1  4/44 (9.09%)  4
mucositis/stomatits (clinical exam)  1  2/44 (4.55%)  2
nausea  1  13/44 (29.55%)  36
taste alteration (dysgeusia)  1  3/44 (6.82%)  3
vomiting  1  11/44 (25.00%)  21
General disorders   
constitutional symptons-other  1  2/44 (4.55%)  2
fatigue  1  21/44 (47.73%)  36
fever (in the absence of neutropenia)  1  7/44 (15.91%)  13
hemorrhage/bleeding-other  1  5/44 (11.36%)  10
insomnia  1  3/44 (6.82%)  3
metabolic/laboratory-other  1  3/44 (6.82%)  3
pain  1  21/44 (47.73%)  42
pain-other  1  4/44 (9.09%)  5
rigors/chills  1  8/44 (18.18%)  10
sweating (diaphoresis)  1  2/44 (4.55%)  5
syndromes-other  1  4/44 (9.09%)  4
weight loss  1  13/44 (29.55%)  13
Infections and infestations   
febrile neutropenia (fever of unknown origin without clinically or microbiologically documentation  1  3/44 (6.82%)  7
infection with normal Anc or grade 1 or 2 neutrophils  1  2/44 (4.55%)  2
infection-other  1  2/44 (4.55%)  2
Investigations   
albumin, serum-low (hypoalbuminemia)  1  8/44 (18.18%)  18
alkaline phosphatase  1  10/44 (22.73%)  14
bilirubin (hyperbilirubinemia)  1  4/44 (9.09%)  8
serum glutamic oxaloacetic transaminase (ALT/SGOT)  1  8/44 (18.18%)  9
serum glutamic pyruvic transaminase (AST/SGPT)  1  7/44 (15.91%)  9
Metabolism and nutrition disorders   
bicarbonate, serum-low  1  5/44 (11.36%)  7
hypocalcemia  1  4/44 (9.09%)  9
hyperglycemia  1  6/44 (13.64%)  9
hyperkalemia  1  2/44 (4.55%)  2
hypernatremia  1  2/44 (4.55%)  2
hypokalemia  1  4/44 (9.09%)  4
hypomagnesemia  1  2/44 (4.55%)  2
hyponatremia  1  4/44 (9.09%)  6
Nervous system disorders   
mood alteration  1  3/44 (6.82%)  4
neuropathy: sensory  1  2/44 (4.55%)  2
Respiratory, thoracic and mediastinal disorders   
dyspnea  1  5/44 (11.36%)  5
hemorrhage (pulmonary/upper respiratory)  1  2/44 (4.55%)  2
hiccoughs  1  2/44 (4.55%)  2
pulmonary/upper respiratory-other  1  2/44 (4.55%)  3
voice changes  1  3/44 (6.82%)  4
Skin and subcutaneous tissue disorders   
bruising  1  2/44 (4.55%)  3
dermatology/skin-other  1  10/44 (22.73%)  18
hair loss/alopecia  1  2/44 (4.55%)  2
nail changes  1  2/44 (4.55%)  2
petechiae/purpura  1  2/44 (4.55%)  2
rash/desquamation  1  10/44 (22.73%)  13
rash: acne/acneiform  1  17/44 (38.64%)  32
rash: hand-foot skin reaction  1  12/44 (27.27%)  22
skin breakdown/decubitus ulcer  1  2/44 (4.55%)  2
Vascular disorders   
thrombosis/thrombus/embolism  1  2/44 (4.55%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Deirdre Cohen, MD
Organization: NYU Cancer Institute
Phone: 212-731-5656
EMail: deirdre.cohen@nyumc.org
Publications:
Kindler HL, K. A. Bylow, H. S. Hochster, G. Friberg, K. Micetich, G. Locker, M. Kozloff, M. Moore, W. Sun, E. E. Vokes, and University Of Chicago Phase II Consortium. A randomized phase II study of bevacizumab (B) and gemcitabine (G) plus cetuximab (C) or erlotinib (E) in patients with advanced pancreatic cancer: A preliminary analysis. J. Clin. Oncol (Meeting Abstracts) June 2006, vol. 24 no. 18_suppl 4040
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00696696     History of Changes
Other Study ID Numbers: NYU 06-882
First Submitted: June 11, 2008
First Posted: June 13, 2008
Results First Submitted: November 18, 2011
Results First Posted: December 21, 2011
Last Update Posted: June 30, 2016