Trial Outcomes & Findings for Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer (NCT NCT00970502)
NCT ID: NCT00970502
Last Updated: 2017-04-10
Results Overview
Number of participants with acute and late toxicity
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
30 DAYS
Results posted on
2017-04-10
Participant Flow
All patients were evaluated by head and neck surgery, medical oncology, and radiation oncology before trial entry. Patients were enrolled at least 6 months after they had completed prior radiation. Patients were enrolled between March 2007 and December 2009.
Participant milestones
| Measure |
Erlotinib + Celecoxib
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Erlotinib + Celecoxib
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib + Celecoxib
n=14 Participants
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
0 participants
n=5 Participants
|
|
ECOG Performance Status
1
|
5 participants
n=5 Participants
|
|
ECOG Performance Status
2
|
9 participants
n=5 Participants
|
|
Tobacco use, pack-years
None to minimal
|
2 participants
n=5 Participants
|
|
Tobacco use, pack-years
<20
|
6 participants
n=5 Participants
|
|
Tobacco use, pack-years
20-40
|
3 participants
n=5 Participants
|
|
Tobacco use, pack-years
>40
|
2 participants
n=5 Participants
|
|
Tobacco use, pack-years
Unknown
|
1 participants
n=5 Participants
|
|
Recurrent vs secondary primary
Primary recurrence
|
7 participants
n=5 Participants
|
|
Recurrent vs secondary primary
Second or later recurrence
|
4 participants
n=5 Participants
|
|
Recurrent vs secondary primary
Second primary cancer
|
3 participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
13 participants
n=5 Participants
|
|
Histology
Adenoid cystic
|
1 participants
n=5 Participants
|
|
Primary Site
Sinonasal
|
3 participants
n=5 Participants
|
|
Primary Site
Ear/facial skin
|
2 participants
n=5 Participants
|
|
Primary Site
Oropharynx
|
3 participants
n=5 Participants
|
|
Primary Site
Oral cavity
|
1 participants
n=5 Participants
|
|
Primary Site
Hypopharynx
|
4 participants
n=5 Participants
|
|
Primary Site
Larynx
|
1 participants
n=5 Participants
|
|
Primary tumor classification
Tx-T3
|
4 participants
n=5 Participants
|
|
Primary tumor classification
T4
|
10 participants
n=5 Participants
|
|
Lymph node status
N0
|
3 participants
n=5 Participants
|
|
Lymph node status
N1
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DAYSPopulation: Erlotinib and celecoxib were administered orally
Number of participants with acute and late toxicity
Outcome measures
| Measure |
Celecoxib 200mg
n=3 Participants
Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
|
Celecoxib 400mg
n=8 Participants
Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
|
Celecoxib 600mg
n=3 Participants
Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
|
|---|---|---|---|
|
Toxicity
|
0 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 20 monthsResponse to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
Outcome measures
| Measure |
Celecoxib 200mg
n=14 Participants
Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
|
Celecoxib 400mg
Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
|
Celecoxib 600mg
Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
|
|---|---|---|---|
|
Clinical Response
Complete Response(CR)
|
6 Participants
|
—
|
—
|
|
Clinical Response
Pathologic partial response (pPR)
|
1 Participants
|
—
|
—
|
|
Clinical Response
Progressive disease (PD)
|
5 Participants
|
—
|
—
|
|
Clinical Response
No evidence of disease (NED)
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 20 monthsPatients with locoregional and/or distant progression
Outcome measures
| Measure |
Celecoxib 200mg
n=14 Participants
Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
|
Celecoxib 400mg
Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
|
Celecoxib 600mg
Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
|
|---|---|---|---|
|
Locoregional Progression
free of disease
|
4 participants
|
—
|
—
|
|
Locoregional Progression
isolated locoregional progression
|
4 participants
|
—
|
—
|
|
Locoregional Progression
isolated distant progression
|
2 participants
|
—
|
—
|
|
Locoregional Progression
both locoregional and distant progression
|
1 participants
|
—
|
—
|
|
Locoregional Progression
no evidence of disease, died of comorbid illness
|
3 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearAt a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.
Outcome measures
| Measure |
Celecoxib 200mg
n=15 Participants
Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
|
Celecoxib 400mg
Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
|
Celecoxib 600mg
Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
|
|---|---|---|---|
|
Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
overall survival rates
|
55 percentage of participants
|
—
|
—
|
|
Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
locoregional control
|
60 percentage of participants
|
—
|
—
|
|
Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
progress-free survival
|
37 percentage of participants
|
—
|
—
|
|
Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
long term toxicity
|
0 percentage of participants
|
—
|
—
|
Adverse Events
Erlotinib + Celecoxib
Serious events: 14 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib + Celecoxib
n=14 participants at risk
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
|
|---|---|
|
Gastrointestinal disorders
pharyngocutaneous fistula
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
folliculitis
|
7.1%
1/14 • Number of events 1
|
|
General disorders
nausea
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
rectal bleeding
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
bone necrosis
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
trismus
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
mucositis
|
21.4%
3/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
1/14
|
|
General disorders
Pain
|
21.4%
3/14
|
|
General disorders
Fatigue
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
Acneiform Rash
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
Metabolic (Na, K, Ca)
|
7.1%
1/14
|
Other adverse events
| Measure |
Erlotinib + Celecoxib
n=14 participants at risk
erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
|
|---|---|
|
Gastrointestinal disorders
Mucositis
|
71.4%
10/14
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
85.7%
12/14
|
|
General disorders
Pain
|
78.6%
11/14
|
|
General disorders
Xerostomia
|
35.7%
5/14
|
|
Blood and lymphatic system disorders
abnormal white blood cell count
|
35.7%
5/14
|
|
Blood and lymphatic system disorders
abnormal hemoglobin count
|
85.7%
12/14
|
|
General disorders
Fatigue
|
21.4%
3/14
|
|
Eye disorders
Dry eye
|
7.1%
1/14
|
|
General disorders
Nausea
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Acneiform rash
|
85.7%
12/14
|
|
Metabolism and nutrition disorders
Metabolic (Na, K, Ca)
|
28.6%
4/14
|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
21.4%
3/14
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14
|
|
Gastrointestinal disorders
Rectal bleeding
|
7.1%
1/14
|
|
Eye disorders
Conjuncitivitis
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place