Trial Outcomes & Findings for Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer (NCT NCT00696696)
NCT ID: NCT00696696
Last Updated: 2016-06-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
4 months
Results posted on
2016-06-30
Participant Flow
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.
One patient was enrolled but then withdrew consent before treatment.
Participant milestones
| Measure |
Combination GES
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Combination GES
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Death
|
3
|
Baseline Characteristics
Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Combination GES
n=45 Participants
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
FULL_RANGE 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Based on the number of patients treated.
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.
Outcome measures
| Measure |
Combination GES
n=44 Participants
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
4-month Progression Free Survival (PFS) Rate
|
49 percentage of patients
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: 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.
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)).
Outcome measures
| Measure |
Combination GES
n=30 Participants
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
Objective Response Rate
|
7 percentage of patients
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Based on the number of patients treated.
Median overall survival is defined as the time when 50% of the patients are alive from the start of the treatment.
Outcome measures
| Measure |
Combination GES
n=44 Participants
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
Median Overall Survival (mOS)
|
195 days
Interval 144.0 to 290.0
|
Adverse Events
Combination GES
Serious events: 14 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination GES
n=44 participants at risk
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
Investigations
AST, SGOT
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
anorexia
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Investigations
bilirubin
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Cardiac disorders
cardiac general
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Nervous system disorders
confusion
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
constitutional symptoms
|
4.5%
2/44 • Number of events 4 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
diarrhea
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Infections and infestations
febrile neutropenia
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
fever
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
hemorrhage (GI)
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Cardiac disorders
hypotension
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Infections and infestations
infection with normal Anc or grade 1 or 2 neutropenia
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Infections and infestations
infection with unknown Anc
|
2.3%
1/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
nausea
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
obstruction
|
2.3%
1/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
perforation
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
vomiting
|
2.3%
1/44 • Number of events 1 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
Other adverse events
| Measure |
Combination GES
n=44 participants at risk
Combination of Gemcitabine, Erlotinib, and Sorafenib
|
|---|---|
|
Investigations
albumin, serum-low (hypoalbuminemia)
|
18.2%
8/44 • Number of events 18 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Investigations
alkaline phosphatase
|
22.7%
10/44 • Number of events 14 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
anorexia
|
29.5%
13/44 • Number of events 21 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
bicarbonate, serum-low
|
11.4%
5/44 • Number of events 7 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Investigations
bilirubin (hyperbilirubinemia)
|
9.1%
4/44 • Number of events 8 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Blood and lymphatic system disorders
blood/bone marrow-other
|
22.7%
10/44 • Number of events 25 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
bruising
|
4.5%
2/44 • Number of events 3 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
constipation
|
9.1%
4/44 • Number of events 5 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
constitutional symptons-other
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
dermatology/skin-other
|
22.7%
10/44 • Number of events 18 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
diarrhea
|
56.8%
25/44 • Number of events 54 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
distension/bloating, abdominal
|
27.3%
12/44 • Number of events 22 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
11.4%
5/44 • Number of events 5 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Blood and lymphatic system disorders
edema: limb
|
13.6%
6/44 • Number of events 11 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
fatigue
|
47.7%
21/44 • Number of events 36 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Infections and infestations
febrile neutropenia (fever of unknown origin without clinically or microbiologically documentation
|
6.8%
3/44 • Number of events 7 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
fever (in the absence of neutropenia)
|
15.9%
7/44 • Number of events 13 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
flatulence
|
11.4%
5/44 • Number of events 12 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
hair loss/alopecia
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Blood and lymphatic system disorders
hemoglobin
|
31.8%
14/44 • Number of events 25 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
hemorrhage (GI)
|
9.1%
4/44 • Number of events 5 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Respiratory, thoracic and mediastinal disorders
hemorrhage (pulmonary/upper respiratory)
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
hemorrhage/bleeding-other
|
11.4%
5/44 • Number of events 10 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
hemorrhoid
|
4.5%
2/44 • Number of events 3 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Respiratory, thoracic and mediastinal disorders
hiccoughs
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
9.1%
4/44 • Number of events 9 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
13.6%
6/44 • Number of events 9 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
hypernatremia
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Cardiac disorders
hypertension
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
hypokalemia
|
9.1%
4/44 • Number of events 4 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Metabolism and nutrition disorders
hyponatremia
|
9.1%
4/44 • Number of events 6 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Infections and infestations
infection with normal Anc or grade 1 or 2 neutrophils
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Infections and infestations
infection-other
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
insomnia
|
6.8%
3/44 • Number of events 3 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Blood and lymphatic system disorders
leukocytes
|
22.7%
10/44 • Number of events 35 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Blood and lymphatic system disorders
lymphopenia
|
18.2%
8/44 • Number of events 27 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
metabolic/laboratory-other
|
6.8%
3/44 • Number of events 3 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Nervous system disorders
mood alteration
|
6.8%
3/44 • Number of events 4 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
mucositis/stomatitis (functional/symptomatic)
|
9.1%
4/44 • Number of events 4 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
mucositis/stomatits (clinical exam)
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
nail changes
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
nausea
|
29.5%
13/44 • Number of events 36 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Nervous system disorders
neuropathy: sensory
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Blood and lymphatic system disorders
neutrophils/granulocytes
|
13.6%
6/44 • Number of events 18 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
pain
|
47.7%
21/44 • Number of events 42 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
pain-other
|
9.1%
4/44 • Number of events 5 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
petechiae/purpura
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary/upper respiratory-other
|
4.5%
2/44 • Number of events 3 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
22.7%
10/44 • Number of events 13 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
rash: acne/acneiform
|
38.6%
17/44 • Number of events 32 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
rash: hand-foot skin reaction
|
27.3%
12/44 • Number of events 22 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
rigors/chills
|
18.2%
8/44 • Number of events 10 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Investigations
serum glutamic oxaloacetic transaminase (ALT/SGOT)
|
18.2%
8/44 • Number of events 9 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Investigations
serum glutamic pyruvic transaminase (AST/SGPT)
|
15.9%
7/44 • Number of events 9 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Skin and subcutaneous tissue disorders
skin breakdown/decubitus ulcer
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
sweating (diaphoresis)
|
4.5%
2/44 • Number of events 5 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
syndromes-other
|
9.1%
4/44 • Number of events 4 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
taste alteration (dysgeusia)
|
6.8%
3/44 • Number of events 3 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Vascular disorders
thrombosis/thrombus/embolism
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Eye disorders
vision-blurred vision
|
4.5%
2/44 • Number of events 2 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Respiratory, thoracic and mediastinal disorders
voice changes
|
6.8%
3/44 • Number of events 4 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
Gastrointestinal disorders
vomiting
|
25.0%
11/44 • Number of events 21 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
|
General disorders
weight loss
|
29.5%
13/44 • Number of events 13 • up to 1 year (treatment period plus 30 days after the treatment)
All the events were included regardless they were related or not related to the treatment drugs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place