Trial Outcomes & Findings for Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery (NCT NCT00837876)
NCT ID: NCT00837876
Last Updated: 2014-06-25
Results Overview
Number of patients with progression-free survival at 8 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
at 8 weeks
Results posted on
2014-06-25
Participant Flow
This study enrolled patients from October 2008 until February 2011.
37 patients consented and went on study. Six patients were ineligible.
Participant milestones
| Measure |
Treatment
Sorafenib + Erlotinib
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Treatment
Sorafenib + Erlotinib
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
disease progression
|
24
|
Baseline Characteristics
Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment
n=37 Participants
Sorafenib + Erlotinib
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 8 weeksPopulation: Patients who received treatment for \>= 8 weeks. 14 study patients were treated for \< 8 weeks due to toxicity (5), disease progression (5), did not receive study drug (1), respiratory failure (1), drug held more than 28 days (1), patient withdrawal (1). The remaining 13 participants did not have a progression-free survival at 8 weeks.
Number of patients with progression-free survival at 8 weeks
Outcome measures
| Measure |
Treatment
n=23 Participants
Sorafenib + Erlotinib
|
|---|---|
|
Number of Patients With Progression-free Survival
|
10 participants
|
SECONDARY outcome
Timeframe: at 4 monthsPopulation: Participants who received treatment for 4 or more months. The remaining 10 participants received treatment for less than 4 months and were not evaluable.
Per RECIST criteria v. 1.0: measurable lesions: CR disappearance of target lesions, PR \> 30% decrease in the sum of the longest diameter (LD) of target lesions, PD \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, SD neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Outcome measures
| Measure |
Treatment
n=27 Participants
Sorafenib + Erlotinib
|
|---|---|
|
Response Rate
Complete Response
|
0 participants
|
|
Response Rate
Partial Response
|
0 participants
|
|
Response Rate
Stable Disease
|
8 participants
|
|
Response Rate
Progressive Disease
|
19 participants
|
SECONDARY outcome
Timeframe: at 4 monthsPopulation: Patients with progression-free survival at 4 months. The remaining 17 patients were not available for evaluation at 4 months due to toxicity (5), disease progression (5), patient withdrawal (1),respiratory failure (1), study drug held more than 28 days (1), and no study drug (1.
Participants with progression-free survival at 4 months.
Outcome measures
| Measure |
Treatment
n=20 Participants
Sorafenib + Erlotinib
|
|---|---|
|
Number of Patients With Progression-free Survival
|
4 participants
|
SECONDARY outcome
Timeframe: every 4 weeks and every 8 weeks in follow-up to resolution of toxicityPopulation: All patients who received treatment with the study drugs. One patient did not receive treatment.
Number of patients with worst-grade toxicity at each of five grades (grade 1 to 5, with 5 most severe) following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death.
Outcome measures
| Measure |
Treatment
n=36 Participants
Sorafenib + Erlotinib
|
|---|---|
|
Number of Patients With Worst Grade Toxicities
number of patients with worst grade toxicity - 1
|
1 participants
|
|
Number of Patients With Worst Grade Toxicities
number of patients with worst grade toxicity - 2
|
5 participants
|
|
Number of Patients With Worst Grade Toxicities
number of patients with worst grade toxicity - 3
|
26 participants
|
|
Number of Patients With Worst Grade Toxicities
number of patients with worst grade toxicity - 4
|
3 participants
|
|
Number of Patients With Worst Grade Toxicities
number of patients with worst grade toxicity - 5
|
1 participants
|
Adverse Events
Treatment
Serious events: 27 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=37 participants at risk
Sorafenib + Erlotinib
|
|---|---|
|
Gastrointestinal disorders
nausea
|
24.3%
9/37 • Number of events 14
|
|
Gastrointestinal disorders
vomiting
|
18.9%
7/37 • Number of events 11
|
|
Metabolism and nutrition disorders
acidosis
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperglycemia
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
dehydration
|
13.5%
5/37 • Number of events 7
|
|
General disorders
Pain, NOS
|
13.5%
5/37 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.1%
3/37 • Number of events 5
|
|
General disorders
death - NOS
|
5.4%
2/37 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
skin rash
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
infection with unknown ANC, artery
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
bladder infection
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
infection, normal ANC
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
infection, Hickman catheter
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
13.5%
5/37 • Number of events 6
|
|
Investigations
hemoglobin
|
5.4%
2/37 • Number of events 3
|
|
General disorders
fatigue
|
10.8%
4/37 • Number of events 4
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.7%
1/37 • Number of events 1
|
|
Psychiatric disorders
confusion
|
13.5%
5/37 • Number of events 7
|
|
Metabolism and nutrition disorders
calcium, serum-low-hypocalcemia
|
5.4%
2/37 • Number of events 2
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
pain in abdomen
|
27.0%
10/37 • Number of events 15
|
|
Gastrointestinal disorders
diarrhea
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
enteritis
|
2.7%
1/37 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
hypocalcemia
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
hypochloremia
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
thrombosis
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
hemorrhage, GI
|
2.7%
1/37 • Number of events 1
|
|
General disorders
fever
|
5.4%
2/37 • Number of events 2
|
|
General disorders
pain, right upper quadrant
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
infection with unknown ANC, blood
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
infection with unknown ANC, wound
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
AST, SGOT
|
5.4%
2/37 • Number of events 2
|
|
Metabolism and nutrition disorders
alkaline phosphatase
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
obstruction, GI
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
infection with unknown ANC, lung
|
2.7%
1/37 • Number of events 2
|
|
Cardiac disorders
cardiac ischemia/infarction
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain in back
|
8.1%
3/37 • Number of events 4
|
|
Gastrointestinal disorders
distension, abdominal
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary, upper respiratory
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
pain in stomach
|
2.7%
1/37 • Number of events 1
|
|
General disorders
edema, limb
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
ammonia level increase
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
appendicitis
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
deep vein thrombosis
|
2.7%
1/37 • Number of events 1
|
Other adverse events
| Measure |
Treatment
n=37 participants at risk
Sorafenib + Erlotinib
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
56.8%
21/37 • Number of events 40
|
|
Gastrointestinal disorders
nausea
|
40.5%
15/37 • Number of events 22
|
|
Metabolism and nutrition disorders
anorexia
|
37.8%
14/37 • Number of events 19
|
|
Gastrointestinal disorders
vomiting
|
27.0%
10/37 • Number of events 11
|
|
Gastrointestinal disorders
dehydration
|
24.3%
9/37 • Number of events 11
|
|
Gastrointestinal disorders
mucositis/stomatitis
|
24.3%
9/37 • Number of events 10
|
|
Gastrointestinal disorders
constipation
|
21.6%
8/37 • Number of events 8
|
|
Gastrointestinal disorders
flatulence
|
21.6%
8/37 • Number of events 10
|
|
Gastrointestinal disorders
heartburn/dyspepsia
|
5.4%
2/37 • Number of events 3
|
|
General disorders
fatigue
|
59.5%
22/37 • Number of events 42
|
|
Metabolism and nutrition disorders
weight loss
|
32.4%
12/37 • Number of events 17
|
|
Metabolism and nutrition disorders
hyperglycemia
|
51.4%
19/37 • Number of events 36
|
|
Investigations
alkaline phosphatase
|
48.6%
18/37 • Number of events 25
|
|
Metabolism and nutrition disorders
AST, SGOT
|
37.8%
14/37 • Number of events 27
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
35.1%
13/37 • Number of events 24
|
|
Metabolism and nutrition disorders
hyponatremia-sodium, low
|
76.9%
10/13 • Number of events 13
|
|
Metabolism and nutrition disorders
hypokalemia
|
24.3%
9/37 • Number of events 15
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
21.6%
8/37 • Number of events 19
|
|
Metabolism and nutrition disorders
hypocalcemia
|
16.2%
6/37 • Number of events 8
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
10.8%
4/37 • Number of events 4
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
10.8%
4/37 • Number of events 10
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
5.4%
2/37 • Number of events 2
|
|
Investigations
hemoglobin
|
45.9%
17/37 • Number of events 33
|
|
Investigations
lymphopenia
|
32.4%
12/37 • Number of events 30
|
|
Investigations
platelets
|
21.6%
8/37 • Number of events 11
|
|
Metabolism and nutrition disorders
leukocytes
|
13.5%
5/37 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
rash-acne/acneiform
|
45.9%
17/37 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
dry skin
|
24.3%
9/37 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
rash-hand-foot skin reaction
|
18.9%
7/37 • Number of events 18
|
|
Gastrointestinal disorders
pain, abdomen NOS
|
24.3%
9/37 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
pain, back
|
16.2%
6/37 • Number of events 8
|
|
Nervous system disorders
pain, headaches
|
8.1%
3/37 • Number of events 3
|
|
Nervous system disorders
dysarthria/voice changes
|
16.2%
6/37 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
10.8%
4/37 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.1%
3/37 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
confusion
|
8.1%
3/37 • Number of events 4
|
|
Psychiatric disorders
depression
|
8.1%
3/37 • Number of events 3
|
|
Nervous system disorders
Neuropathy-sensory
|
8.1%
3/37 • Number of events 4
|
|
General disorders
edema limb
|
8.1%
3/37 • Number of events 3
|
|
General disorders
constitutional symptoms, other
|
18.9%
7/37 • Number of events 21
|
|
Metabolism and nutrition disorders
albumin, serum-low
|
40.5%
15/37 • Number of events 21
|
|
Metabolism and nutrition disorders
glucose, serum-high-hyperglycemia
|
18.9%
7/37 • Number of events 8
|
|
Gastrointestinal disorders
Taste alteration
|
8.1%
3/37 • Number of events 4
|
|
Infections and infestations
fever (in the absence of neutropenia , where neutropenia is defined as ANC<1.0 x 10e9/L)
|
8.1%
3/37 • Number of events 4
|
|
Nervous system disorders
Insomnia
|
5.4%
2/37 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
sweating
|
5.4%
2/37 • Number of events 2
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory, other
|
5.4%
2/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
dermatology/Skin, other
|
8.1%
3/37 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pruritis, itching
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pain-chest/thorax
|
5.4%
2/37 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pain-sinus
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
pain-throat/pharynx/larynx
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory, other
|
5.4%
2/37 • Number of events 2
|
|
Nervous system disorders
Tremor
|
5.4%
2/37 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
16.2%
6/37 • Number of events 10
|
|
Infections and infestations
Infection-other
|
5.4%
2/37 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC-upper airway NOS
|
5.4%
2/37 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
8.1%
3/37 • Number of events 3
|
|
Vascular disorders
Vascular-other
|
5.4%
2/37 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place