Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00970502
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Johnny Kao, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer of the Pharynx
Cancer of the Larynx
Cancer of the Neck
Paranasal Sinus Neoplasms
Cancer of the Head
Intervention Drug: erlotinib + celecoxib
Enrollment 15
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Erlotinib + Celecoxib
Hide Arm/Group Description 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
Period Title: Overall Study
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Erlotinib + Celecoxib
Hide Arm/Group Description 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 Number of Baseline Participants 14
Hide Baseline Analysis Population Description
15 subjects consented, one withdrew before receiving study treatment and was excluded from analysis
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
64
(43 to 93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
3
  21.4%
Male
11
  78.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  14.3%
White
10
  71.4%
More than one race
0
   0.0%
Unknown or Not Reported
2
  14.3%
ECOG Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
0 0
1 5
2 9
[1]
Measure Description:

The Eastern Cooperative Oncology Group (ECOG) 0 - Fully active, able to carry on all pre-disease performance without restriction

1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours

Tobacco use, pack-years  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
None to minimal 2
<20 6
20-40 3
>40 2
Unknown 1
Recurrent vs secondary primary  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
Primary recurrence 7
Second or later recurrence 4
Second primary cancer 3
Histology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
Squamous cell carcinoma 13
Adenoid cystic 1
Primary Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
Sinonasal 3
Ear/facial skin 2
Oropharynx 3
Oral cavity 1
Hypopharynx 4
Larynx 1
Primary tumor classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
Tx-T3 4
T4 10
[1]
Measure Description: T4 --> Tumor of any size with direct extension to chest wall or skin Tx - T3 --> any tumor not classified as T4
Lymph node status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
N0 3
N1 11
[1]
Measure Description: N0 - tumor cells absent from regional lymph nodes N1 - regional lymph node metastasis present; (at some sites; tumor spread to closest or small number of regional lymph nodes)
1.Primary Outcome
Title Toxicity
Hide Description Number of participants with acute and late toxicity
Time Frame 30 DAYS
Hide Outcome Measure Data
Hide Analysis Population Description
Erlotinib and celecoxib were administered orally
Arm/Group Title Celecoxib 200mg Celecoxib 400mg Celecoxib 600mg
Hide Arm/Group Description:
Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
Overall Number of Participants Analyzed 3 8 3
Measure Type: Number
Unit of Measure: participants
0 1 2
2.Secondary Outcome
Title Clinical Response
Hide Description Response 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
Time Frame 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib + Celecoxib
Hide Arm/Group Description:
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 Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response(CR)
6
  42.9%
Pathologic partial response (pPR)
1
   7.1%
Progressive disease (PD)
5
  35.7%
No evidence of disease (NED)
2
  14.3%
3.Secondary Outcome
Title Locoregional Progression
Hide Description Patients with locoregional and/or distant progression
Time Frame 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib + Celecoxib
Hide Arm/Group Description:
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 Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
free of disease 4
isolated locoregional progression 4
isolated distant progression 2
both locoregional and distant progression 1
no evidence of disease, died of comorbid illness 3
4.Secondary Outcome
Title Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity
Hide Description At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erlotinib + Celecoxib
Hide Arm/Group Description:
Recommended dose of celecoxib was 400mg
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: percentage of participants
locoregional control 60
progress-free survival 37
overall survival rates 55
long term toxicity 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib + Celecoxib
Hide Arm/Group Description 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
All-Cause Mortality
Erlotinib + Celecoxib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib + Celecoxib
Affected / at Risk (%) # Events
Total   14/14 (100.00%)    
Gastrointestinal disorders   
pharyngocutaneous fistula  1/14 (7.14%)  1
rectal bleeding  1/14 (7.14%)  1
mucositis  3/14 (21.43%) 
General disorders   
nausea  1/14 (7.14%)  1
Pain  3/14 (21.43%) 
Fatigue  2/14 (14.29%) 
Metabolism and nutrition disorders   
Metabolic (Na, K, Ca)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders   
bone necrosis  1/14 (7.14%)  1
trismus  1/14 (7.14%)  1
Skin and subcutaneous tissue disorders   
folliculitis  1/14 (7.14%)  1
Dermatitis  1/14 (7.14%) 
Acneiform Rash  1/14 (7.14%) 
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erlotinib + Celecoxib
Affected / at Risk (%) # Events
Total   14/14 (100.00%)    
Blood and lymphatic system disorders   
abnormal white blood cell count  5/14 (35.71%) 
abnormal hemoglobin count  12/14 (85.71%) 
Eye disorders   
Dry eye  1/14 (7.14%) 
Conjuncitivitis  1/14 (7.14%) 
Gastrointestinal disorders   
Mucositis  10/14 (71.43%) 
Diarrhea  1/14 (7.14%) 
Rectal bleeding  1/14 (7.14%) 
General disorders   
Pain  11/14 (78.57%) 
Xerostomia  5/14 (35.71%) 
Fatigue  3/14 (21.43%) 
Nausea  1/14 (7.14%) 
Hepatobiliary disorders   
Elevated Liver Function Tests  3/14 (21.43%) 
Metabolism and nutrition disorders   
Metabolic (Na, K, Ca)  4/14 (28.57%) 
Skin and subcutaneous tissue disorders   
Dermatitis  12/14 (85.71%) 
Acneiform rash  12/14 (85.71%) 
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Johnny Kao
Organization: Florida Radiation Oncology Group
Phone: 813-661-6442
EMail: johnnykaomd@gmail.com
Layout table for additonal information
Responsible Party: Johnny Kao, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00970502     History of Changes
Other Study ID Numbers: GCO 06-0509
First Submitted: September 1, 2009
First Posted: September 2, 2009
Results First Submitted: December 23, 2016
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017