Trial Outcomes & Findings for UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer (NCT NCT00570232)
NCT ID: NCT00570232
Last Updated: 2015-05-21
Results Overview
Number of participants who had the most frequently observed undesirable effects after exposure to study drug
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
12 - 24 months
Results posted on
2015-05-21
Participant Flow
Participant milestones
| Measure |
Tarceva
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Tarceva
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
discontinued due to medical condition
|
3
|
|
Overall Study
discontinued due to recurrence
|
8
|
|
Overall Study
discontinued due to noncompliance
|
2
|
Baseline Characteristics
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Tarceva
n=31 Participants
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
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
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
ECOG performance status
0
|
18 participants
n=5 Participants
|
|
ECOG performance status
1
|
8 participants
n=5 Participants
|
|
ECOG performance status
2
|
2 participants
n=5 Participants
|
|
ECOG performance status
unknown
|
3 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Primary Tumor Stage (T)
T1
|
1 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Primary Tumor Stage (T)
T2
|
3 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Primary Tumor Stage (T)
T3
|
6 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Primary Tumor Stage (T)
T4
|
13 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Primary Tumor Stage (T)
not specified
|
8 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Regional Metastasis (N)
N0
|
18 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Regional Metastasis (N)
N1
|
2 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Regional Metastasis (N)
N2
|
2 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Regional Metastasis (N)
N3
|
1 participants
n=5 Participants
|
|
Tumor Stage at Study Start - Regional Metastasis (N)
not specified
|
8 participants
n=5 Participants
|
|
Extent of recurrence
Local
|
21 participants
n=5 Participants
|
|
Extent of recurrence
Regional
|
5 participants
n=5 Participants
|
|
Extent of recurrence
Locoregional
|
5 participants
n=5 Participants
|
|
Tumor subsite
oral cavity
|
11 participants
n=5 Participants
|
|
Tumor subsite
larynx
|
7 participants
n=5 Participants
|
|
Tumor subsite
hypopharynx
|
3 participants
n=5 Participants
|
|
Tumor subsite
oropharynx
|
9 participants
n=5 Participants
|
|
Tumor subsite
unknown
|
1 participants
n=5 Participants
|
|
Procedure details
Coincident tracheostomy
|
13 participants
n=5 Participants
|
|
Procedure details
Coincident PEG
|
11 participants
n=5 Participants
|
|
Procedure details
None
|
7 participants
n=5 Participants
|
|
Flap reconstruction
Yes
|
27 participants
n=5 Participants
|
|
Flap reconstruction
No
|
4 participants
n=5 Participants
|
|
Neck dissection
Unilateral
|
9 participants
n=5 Participants
|
|
Neck dissection
Bilateral
|
12 participants
n=5 Participants
|
|
Neck dissection
None
|
10 participants
n=5 Participants
|
|
Histological tumor grade
Well differentiated
|
1 participants
n=5 Participants
|
|
Histological tumor grade
Moderately differentiated
|
14 participants
n=5 Participants
|
|
Histological tumor grade
Poorly differentiated
|
7 participants
n=5 Participants
|
|
Histological tumor grade
Not specified
|
9 participants
n=5 Participants
|
|
Histological features
Perineural invasion present
|
10 participants
n=5 Participants
|
|
Histological features
Lymphovascular invasion present
|
4 participants
n=5 Participants
|
|
Histological features
Positive lymph nodes
|
4 participants
n=5 Participants
|
|
Histological features
None
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 - 24 monthsNumber of participants who had the most frequently observed undesirable effects after exposure to study drug
Outcome measures
| Measure |
Tarceva
n=31 Participants
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
rash
|
26 participants
|
|
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
diarrhea
|
22 participants
|
|
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
fatigue
|
22 participants
|
|
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
nausea
|
6 participants
|
|
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
vomiting
|
6 participants
|
|
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
headache
|
4 participants
|
PRIMARY outcome
Timeframe: 12 - 24 monthsPercentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)
Outcome measures
| Measure |
Tarceva
n=31 Participants
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
Percentage of Participants With Disease Free Status at 12 Months and 24 Months
disease free rate at 12 months
|
54 percentage of participants
|
|
Percentage of Participants With Disease Free Status at 12 Months and 24 Months
disease free rate at 24 months
|
45 percentage of participants
|
SECONDARY outcome
Timeframe: 12 - 24 monthsPercentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy
Outcome measures
| Measure |
Tarceva
n=31 Participants
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
survival rate at 12 months
|
61 percentage of participants
|
|
Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.
survival rate at 24 months
|
56 percentage of participants
|
Adverse Events
Tarceva
Serious events: 9 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tarceva
n=31 participants at risk
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonia leading to respiratory failure
|
3.2%
1/31 • Number of events 1
|
|
Surgical and medical procedures
bleeding from throat
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
stridor
|
3.2%
1/31 • Number of events 1
|
|
Nervous system disorders
Bell's Palsy
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
3.2%
1/31 • Number of events 2
|
|
Cardiac disorders
cardiac stents placed
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
H pylori infection
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
myocardial infarction
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
3.2%
1/31 • Number of events 1
|
Other adverse events
| Measure |
Tarceva
n=31 participants at risk
All patients will be prescribed Tarceva 150mg daily
Erlotinib: 150 mg per day by mouth for 12 months
|
|---|---|
|
Metabolism and nutrition disorders
hyponatremia
|
12.9%
4/31
|
|
Skin and subcutaneous tissue disorders
hirsutism
|
9.7%
3/31
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
22.6%
7/31
|
|
Gastrointestinal disorders
nausea
|
19.4%
6/31
|
|
Gastrointestinal disorders
vomiting
|
19.4%
6/31
|
|
Investigations
weight loss
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
decreased platelet count
|
16.1%
5/31
|
|
Metabolism and nutrition disorders
hyperkalemia
|
12.9%
4/31
|
|
Metabolism and nutrition disorders
hypercalcemia
|
12.9%
4/31
|
|
Nervous system disorders
headache
|
12.9%
4/31
|
|
Gastrointestinal disorders
constipation
|
12.9%
4/31
|
|
Skin and subcutaneous tissue disorders
acniform rash
|
83.9%
26/31
|
|
General disorders
fatigue
|
71.0%
22/31
|
|
Gastrointestinal disorders
diarrhea
|
71.0%
22/31
|
|
Metabolism and nutrition disorders
hyperglycemia
|
67.7%
21/31
|
|
Metabolism and nutrition disorders
anemia
|
41.9%
13/31
|
|
Skin and subcutaneous tissue disorders
dry skin
|
38.7%
12/31
|
|
Gastrointestinal disorders
dyspepsia
|
9.7%
3/31
|
|
Psychiatric disorders
depression
|
9.7%
3/31
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
9.7%
3/31
|
|
Gastrointestinal disorders
reflux
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
6.5%
2/31
|
|
Skin and subcutaneous tissue disorders
alopecia
|
6.5%
2/31
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
6.5%
2/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place