Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cetuximab, Chemotherapy, and Radiation Therapy for Operable Stage III or IV 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: NCT00089297
Recruitment Status : Completed
First Posted : August 5, 2004
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Interventions Biological: Cetuximab
Drug: Carboplatin
Drug: Paclitaxel
Radiation: Radiation therapy
Enrollment 74
Recruitment Details The study was activated on December 15, 2004 and was closed to accrual on February 6, 2006 after accruing 74 patients.
Pre-assignment Details  
Arm/Group Title Cetuximab/Paclitaxel/Carboplatin
Hide Arm/Group Description

Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.

Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).

Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.

Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.

Period Title: Overall Study
Started 74
Treated 70
Eligible 63
Completed 36
Not Completed 38
Reason Not Completed
Adverse Event             9
Death             1
Withdrawal by Subject             12
Disease progression             2
Ineligible             11
Secondary malignancy             1
IRB approval not ready             1
Non-compliance             1
Arm/Group Title Cetuximab/Paclitaxel/Carboplatin
Hide Arm/Group Description

Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.

Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).

Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.

Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.

Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 63 participants
57
(31 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
14
  22.2%
Male
49
  77.8%
1.Primary Outcome
Title Event-free Survival Rate at 1 Year
Hide Description Event-free survival rate at 1 year was defined as the proportion of patients who did not have disease progression, primary site surgery, or death after being followed for 1 year.
Time Frame Assessed at 1 year.
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients are included in the analysis.
Arm/Group Title Cetuximab/Paclitaxel/Carboplatin
Hide Arm/Group Description:

Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.

Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).

Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.

Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.

Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of patients
0.79
(0.69 to 0.89)
2.Secondary Outcome
Title Proportion of Patients With Objective Response by RECIST
Hide Description Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.
Time Frame Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients are included in this analysis.
Arm/Group Title Cetuximab/Paclitaxel/Carboplatin
Hide Arm/Group Description:

Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.

Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).

Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.

Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.

Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of patients
0.86
(0.75 to 0.93)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival was defined as the time from registration to documented progression or death without progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.
Time Frame Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients are included in the analysis.
Arm/Group Title Cetuximab/Paclitaxel/Carboplatin
Hide Arm/Group Description:

Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.

Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).

Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.

Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.

Overall Number of Participants Analyzed 63
Median (95% Confidence Interval)
Unit of Measure: Months
47.5 [1] 
(32.6 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from registration to death of any causes.
Time Frame Weekly during treatment, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients are included in the analysis.
Arm/Group Title Cetuximab/Paclitaxel/Carboplatin
Hide Arm/Group Description:

Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.

Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).

Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.

Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.

Overall Number of Participants Analyzed 63
Median (95% Confidence Interval)
Unit of Measure: Months
49.4 [1] 
(47.5 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Time Frame Assessed weekly while on treatment and for 30 days after the end of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cetuximab/Paclitaxel/Carboplatin
Hide Arm/Group Description

Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.

Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).

Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.

Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks.

All-Cause Mortality
Cetuximab/Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Cetuximab/Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   64/70 (91.43%) 
Blood and lymphatic system disorders   
Anemia  1  1/70 (1.43%) 
Febrile neutropenia  1  2/70 (2.86%) 
Gastrointestinal disorders   
Diarrhea w/o prior colostomy  1  3/70 (4.29%) 
Dry mouth  1  4/70 (5.71%) 
Dysphagia  1  20/70 (28.57%) 
Esophagitis  1  1/70 (1.43%) 
Muco/stomatitis by exam, oral cavity  1  2/70 (2.86%) 
Muco/stomatitis (symptom) oral cavity  1  35/70 (50.00%) 
Nausea  1  2/70 (2.86%) 
Vomiting  1  2/70 (2.86%) 
Esophagus, pain  1  1/70 (1.43%) 
Oral cavity, pain  1  4/70 (5.71%) 
General disorders   
Fatigue  1  6/70 (8.57%) 
Immune system disorders   
Allergic reaction  1  3/70 (4.29%) 
Infections and infestations   
Infection Gr0-2 neut, bladder  1  1/70 (1.43%) 
Infection Gr0-2 neut, catheter  1  2/70 (2.86%) 
Infection Gr0-2 neut, colon  1  2/70 (2.86%) 
Infection Gr0-2 neut, foreign body  1  2/70 (2.86%) 
Infection Gr0-2 neut, mucosa  1  2/70 (2.86%) 
Infection Gr0-2 neut, oral cavity  1  2/70 (2.86%) 
Infection Gr0-2 neut, pharynx  1  2/70 (2.86%) 
Infection Gr0-2 neut, skin  1  1/70 (1.43%) 
Infection Gr0-2 neut, urinary tract  1  1/70 (1.43%) 
Infection w/ unk ANC wound  1  1/70 (1.43%) 
Injury, poisoning and procedural complications   
Burn  1  1/70 (1.43%) 
Radiation dermatitis  1  16/70 (22.86%) 
Investigations   
Leukocytes, decreased  1  28/70 (40.00%) 
Lymphopenia  1  4/70 (5.71%) 
Neutrophils, decreased  1  31/70 (44.29%) 
Weight loss  1  7/70 (10.00%) 
Blood bilirubin increased  1  2/70 (2.86%) 
Creatinine, increased  1  1/70 (1.43%) 
Metabolism and nutrition disorders   
Anorexia  1  13/70 (18.57%) 
Dehydration  1  7/70 (10.00%) 
Hypocalcemia  1  1/70 (1.43%) 
Hyperglycemia  1  1/70 (1.43%) 
Hypomagnesemia  1  3/70 (4.29%) 
Hypophosphatemia  1  3/70 (4.29%) 
Hyperkalemia  1  1/70 (1.43%) 
Hypokalemia  1  2/70 (2.86%) 
Hyponatremia  1  1/70 (1.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/70 (1.43%) 
Nervous system disorders   
Neuropathy-motor  1  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders   
Muco/stomatitis (symptom) pharynx  1  1/70 (1.43%) 
Throat/pharynx/larynx, pain  1  2/70 (2.86%) 
Bronchospasm, wheezing  1  1/70 (1.43%) 
Dyspnea  1  2/70 (2.86%) 
Obstruction, airway-larynx  1  1/70 (1.43%) 
Voice changes/dysarthria  1  3/70 (4.29%) 
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  3/70 (4.29%) 
Rash: acne/acneiform  1  8/70 (11.43%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  1/70 (1.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cetuximab/Paclitaxel/Carboplatin
Affected / at Risk (%)
Total   70/70 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  62/70 (88.57%) 
Eye disorders   
Dry eye syndrome  1  4/70 (5.71%) 
Ocular surface disease  1  4/70 (5.71%) 
Vision-blurred  1  4/70 (5.71%) 
Gastrointestinal disorders   
Constipation  1  26/70 (37.14%) 
Diarrhea w/o prior colostomy  1  16/70 (22.86%) 
Dry mouth  1  50/70 (71.43%) 
Dysphagia  1  48/70 (68.57%) 
Dyspepsia  1  7/70 (10.00%) 
Muco/stomatitis (symptom) oral cavity  1  51/70 (72.86%) 
Nausea  1  31/70 (44.29%) 
Vomiting  1  19/70 (27.14%) 
Oral cavity, pain  1  10/70 (14.29%) 
General disorders   
Fatigue  1  55/70 (78.57%) 
Fever w/o neutropenia  1  13/70 (18.57%) 
Edema limb  1  4/70 (5.71%) 
Infections and infestations   
Infection Gr0-2 neut, oral cavity  1  6/70 (8.57%) 
Infection Gr0-2 neut, ungual  1  4/70 (5.71%) 
Injury, poisoning and procedural complications   
Radiation dermatitis  1  44/70 (62.86%) 
Investigations   
Leukocytes, decreased  1  61/70 (87.14%) 
Lymphopenia  1  5/70 (7.14%) 
Neutrophils, decreased  1  35/70 (50.00%) 
Platelets, decreased  1  19/70 (27.14%) 
Weight loss  1  42/70 (60.00%) 
Activated partial thromboplastin time prolonged  1  5/70 (7.14%) 
Alanine aminotransferase increased  1  36/70 (51.43%) 
Aspartate aminotransferase increased  1  31/70 (44.29%) 
Blood bilirubin increased  1  9/70 (12.86%) 
Creatinine, increased  1  4/70 (5.71%) 
Metabolism and nutrition disorders   
Anorexia  1  28/70 (40.00%) 
Dehydration  1  7/70 (10.00%) 
Hypoalbuminemia  1  8/70 (11.43%) 
Hypocalcemia  1  7/70 (10.00%) 
Hyperglycemia  1  9/70 (12.86%) 
Hypomagnesemia  1  15/70 (21.43%) 
Hypokalemia  1  9/70 (12.86%) 
Hyponatremia  1  4/70 (5.71%) 
Musculoskeletal and connective tissue disorders   
Trismus  1  6/70 (8.57%) 
Joint, pain  1  12/70 (17.14%) 
Muscle, pain  1  12/70 (17.14%) 
Neck, pain  1  4/70 (5.71%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  5/70 (7.14%) 
Nervous system disorders   
Taste disturbance  1  21/70 (30.00%) 
Dizziness  1  8/70 (11.43%) 
Neuropathy-sensory  1  24/70 (34.29%) 
Head/headache  1  11/70 (15.71%) 
Psychiatric disorders   
Insomnia  1  7/70 (10.00%) 
Depression  1  14/70 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Nose, hemorrhage  1  4/70 (5.71%) 
Throat/pharynx/larynx, pain  1  7/70 (10.00%) 
Cough  1  9/70 (12.86%) 
Voice changes/dysarthria  1  9/70 (12.86%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  16/70 (22.86%) 
Alopecia  1  45/70 (64.29%) 
Nail changes  1  8/70 (11.43%) 
Pruritus/itching  1  11/70 (15.71%) 
Rash/desquamation  1  24/70 (34.29%) 
Rash: acne/acneiform  1  64/70 (91.43%) 
Vascular disorders   
Hypotension  1  7/70 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Publications of Results:
Wanebo HJ, Ghebremichael M, Burtness B, et al.: Phase II evaluation of cetuximab (C225) combined with induction paclitaxel and carboplatin followed by C225, paclitaxel, carboplatin, and radiation for stage III/IV operable squamous cancer of the head and neck (ECOG, E2303). [Abstract] J Clin Oncol 25 (Suppl 18): A-6015, 302s, 2007.
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00089297    
Other Study ID Numbers: CDR0000378194
U10CA021115 ( U.S. NIH Grant/Contract )
E2303 ( Other Identifier: Eastern Cooperative Oncology Group )
First Submitted: August 4, 2004
First Posted: August 5, 2004
Results First Submitted: December 31, 2012
Results First Posted: March 11, 2013
Last Update Posted: March 11, 2013