Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)

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: NCT00343083
Recruitment Status : Completed
First Posted : June 22, 2006
Results First Posted : April 9, 2014
Last Update Posted : March 16, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer of Head and Neck
Interventions Drug: Erbitux, Paclitaxel & Carboplatin
Radiation: Radiation
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cetuximab (ERBITUX) and Concurrent Carboplatin
Hide Arm/Group Description

. Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week.

The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV.

Period Title: Overall Study
Started 43
Completed 22
Not Completed 21
Arm/Group Title Cetuximab (ERBITUX) and Concurrent Carboplatin
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
0
   0.0%
Between 18 and 65 years
35
  81.4%
>=65 years
8
  18.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
6
  14.0%
Male
37
  86.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy.
Hide Description The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Concurrent Chemo Raditaion Wtih Cetuximab
Hide Arm/Group Description:
The addition of CTX to weekly PC and daily RT.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
43
2.Secondary Outcome
Title Local Regional Control at 2 Years
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Concurrent Chemo Raditaion Wtih Cetuximab
Hide Arm/Group Description:
The addition of CTX to weekly PC and daily RT.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
72
3.Secondary Outcome
Title Overall Survival and Disease-free Survival
Hide Description [Not Specified]
Time Frame 3 years (overall) 2 years disease-free
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Concurrent Chemo Raditaion Wtih Cetuximab
Hide Arm/Group Description:
The addition of CTX to weekly PC and daily RT.
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
overall survival 59
disease-free survival 58
4.Secondary Outcome
Title Pathological Response to Cetuximab
Hide Description Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Concurrent Chemo Raditaion Wtih Cetuximab
Hide Arm/Group Description:
The addition of CTX to weekly PC and daily RT
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
43
5.Secondary Outcome
Title Percentage of Participants With Grade 3 Toxicities of Cetuximab
Hide Description

One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible.

Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity.

Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Concurrent Chemo Raditaion Wtih Cetuximab
Hide Arm/Group Description:
The addition of CTX to weekly PC and daily RT
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
mucositis 79
rash 9
leukopenia 19
neutropenia 19
RT dermatisis 16
6.Secondary Outcome
Title Clinical Complete Response Rate of This Regimen in the Population
Hide Description What is the the complete response (CR) rate at the completion of therapy.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Concurrent Chemo Raditaion Wtih Cetuximab
Hide Arm/Group Description:
The addition of CTX to weekly PC and daily RT
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: percentage of participants
84
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cetuximab (ERBITUX) and Concurrent Carboplatin
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Cetuximab (ERBITUX) and Concurrent Carboplatin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cetuximab (ERBITUX) and Concurrent Carboplatin
Affected / at Risk (%) # Events
Total   3/43 (6.98%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Anaphylactic reaction  [1]  3/43 (6.98%)  3
Indicates events were collected by systematic assessment
[1]
3 patients developed a Grade IV anaphylactic reaction to the loading dose of Erbitux (week 1) and were taken off protocol hence withdrawn due to toxicity.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cetuximab (ERBITUX) and Concurrent Carboplatin
Affected / at Risk (%) # Events
Total   0/43 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ritesh Kataria
Organization: University of Maryland Baltimore
Phone: 410-328-8018
Responsible Party: Department of Radiation Oncology, University of Maryland
ClinicalTrials.gov Identifier: NCT00343083     History of Changes
Other Study ID Numbers: HP-00042712
CA225092
First Submitted: June 20, 2006
First Posted: June 22, 2006
Results First Submitted: April 12, 2013
Results First Posted: April 9, 2014
Last Update Posted: March 16, 2016