Trial Outcomes & Findings for Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer (NCT NCT00470535)
NCT ID: NCT00470535
Last Updated: 2017-02-23
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Every cycle for up to 52 weeks
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
Erlotinib (Tarceva)
Erlotinib 150mg orally daily for three weeks
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Erlotinib (Tarceva)
Erlotinib 150mg orally daily for three weeks
|
|---|---|
|
Overall Study
Disease Progression
|
13
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib (Tarceva)
n=18 Participants
Erlotinib 150mg orally daily for three weeks
|
|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every cycle for up to 52 weeksPopulation: All treated and eligible patients
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
Outcome measures
| Measure |
Erlotinib (Tarceva)
n=18 Participants
Erlotinib 150mg orally daily for three weeks
|
|---|---|
|
Progression-free Survival
|
1.4 months
Interval 1.2 to 1.4
|
SECONDARY outcome
Timeframe: After every cyclePopulation: This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After every cyclePopulation: This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 weeksPopulation: This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 3 weeksPopulation: This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At BaselinePopulation: This study was terminated earlier due to a phase III study that showed this drug was not better than sorafenib so it didn't make sense to offer an inferior drug to patients.
Outcome measures
Outcome data not reported
Adverse Events
Erlotinib (Tarceva)
Serious events: 9 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib (Tarceva)
n=18 participants at risk
Erlotinib 150mg orally daily for three weeks
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Death
|
22.2%
4/18 • Number of events 4
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct obstruction
|
5.6%
1/18 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Blood glucose
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Failure to thrive
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.6%
1/18 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Erlotinib (Tarceva)
n=18 participants at risk
Erlotinib 150mg orally daily for three weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
9/18 • Number of events 17
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.6%
1/18 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
27.8%
5/18 • Number of events 6
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
3/18 • Number of events 4
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
27.8%
5/18 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
27.8%
5/18 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
44.4%
8/18 • Number of events 12
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
2/18 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
38.9%
7/18 • Number of events 8
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
6/18 • Number of events 6
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Chills
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Facial pain
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Fatigue
|
66.7%
12/18 • Number of events 16
|
|
General disorders
Influenza like illness
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1
|
|
General disorders
Oedema
|
5.6%
1/18 • Number of events 2
|
|
General disorders
Oedema peripheral
|
27.8%
5/18 • Number of events 5
|
|
General disorders
Pain
|
11.1%
2/18 • Number of events 3
|
|
Hepatobiliary disorders
Cholangiolitis
|
5.6%
1/18 • Number of events 2
|
|
Hepatobiliary disorders
Cholangitis
|
5.6%
1/18 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
22.2%
4/18 • Number of events 6
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
16.7%
3/18 • Number of events 5
|
|
Investigations
Alanine aminotransferase
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
4/18 • Number of events 5
|
|
Investigations
Aspartate aminotransferase
|
5.6%
1/18 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
8/18 • Number of events 13
|
|
Investigations
Blood alkaline phosphatase
|
44.4%
8/18 • Number of events 12
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
3/18 • Number of events 3
|
|
Investigations
Blood creatinine
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Haemoglobin decreased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
International normalised ratio increased
|
11.1%
2/18 • Number of events 2
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Prothrombin level abnormal
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Weight decreased
|
16.7%
3/18 • Number of events 4
|
|
Metabolism and nutrition disorders
Decreased appetite
|
66.7%
12/18 • Number of events 12
|
|
Metabolism and nutrition disorders
Dehydration
|
27.8%
5/18 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
55.6%
10/18 • Number of events 24
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
27.8%
5/18 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
9/18 • Number of events 18
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.1%
2/18 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
6/18 • Number of events 9
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
6/18 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
3/18 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
16.7%
3/18 • Number of events 3
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
2/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
2/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
38.9%
7/18 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place