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Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00226239
Recruitment Status : Completed
First Posted : September 26, 2005
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Interventions Drug: Docetaxel
Drug: Cisplatin
Drug: Cetuximab
Procedure: Radiation Therapy
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
Period Title: TPE, Induction Therapy
Started 39
Completed 37
Not Completed 2
Period Title: XPE, Definitive Therapy
Started 37
Completed 33
Not Completed 4
Period Title: Maintenance Cetuximab
Started 31
Completed 17
Not Completed 14
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
55
(21 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
5
  12.8%
Male
34
  87.2%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles.
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description:
Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles
Overall Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86
(75 to 98)
2.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on Response Evaluation Criteria in Solid Tumors (RECIST), version 1.0.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE).
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description:
Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(91 to 100)
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is an estimated percentage of participants without disease progression at two years (or three years) after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0. The two-year and three-year PFS ended up being the same in this study.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description:
Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
two-year PFS
70
(53 to 82)
three-year PFS
70
(53 to 82)
4.Secondary Outcome
Title 2-year Overall Survival (OS)
Hide Description Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description:
Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84
(68 to 93)
5.Secondary Outcome
Title 3-year Overall Survival (OS)
Hide Description Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.
Time Frame Up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that started were evaluable for this outcome measure, except for the one patient removed from study due to hypersensitivity reaction on cycle 1, day 1.
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description:
Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74
(54 to 86)
6.Secondary Outcome
Title Quality of Life (QOL)
Hide Description Effect of treatment on acute and late QOL and functional status using Functional Assessment of Cancer Therapy–General (FACT-G) with FACT-Head and Neck (FACT-HN) subscale. The instructions to the participant were: "Below is a list of statements that other people with your illness have said are important. By circling one number per line, please indicate how true each statement has been for you during the past 7 days." The choices for each statement ranged from 0 (not at all) to 4 (very much). The FACT-G and FACT-Head and Neck total scores were computed by summing 27 and 39 questions respectively, for four subscales: physical well-being, social well-being, emotional well-being, and functional well-being. Questions for both assessments are phrased so that higher numbers/values indicate a better health state.
Time Frame Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed using all responses actually obtained.
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description:
Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
FACT-G Total Score Pre-treatment Number Analyzed 30 participants
77.4311  (16.56741)
FACT-G Total Score Post-induction Number Analyzed 22 participants
75.6303  (15.68977)
FACT-G Total Score 3 months after XPE Number Analyzed 22 participants
71.3864  (17.51042)
FACT-G Total Score 12 months after XPE Number Analyzed 19 participants
86.6702  (18.82226)
FACT-HN Pre-treatment Number Analyzed 30 participants
25.7000  (6.74230)
FACT-HN Post-induction Number Analyzed 22 participants
25.1250  (7.42332)
FACT-HN 3 months after XPE Number Analyzed 22 participants
19.4545  (5.01167)
FACT-HN 12 months after XPE Number Analyzed 19 participants
24.5263  (7.50088)
7.Other Pre-specified Outcome
Title EGFR-related Serum Markers
Hide Description Evaluation of changes in serum markers (EGFR-related) before and after therapy in the above patient population, and expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers.
Time Frame Up to 36 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Head and Neck Cancer Patients
Hide Arm/Group Description Patients with locally advanced HNC, including squamous and undifferentiated histologies, treated with docetaxel 75 mg/m^2 day 1, cisplatin 75 mg/m^2 day 1, and cetuximab 250 mg/m^2 days 1, 8, and 15 (after an initial loading dose of 400 mg/m^2), termed TPE, repeated every 21 days for three cycles, followed by radiotherapy with concurrent cisplatin 30 mg/m^2 and cetuximab weekly (XPE), and maintenance cetuximab for 6 months.
All-Cause Mortality
Head and Neck Cancer Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Head and Neck Cancer Patients
Affected / at Risk (%)
Total   32/39 (82.05%) 
Blood and lymphatic system disorders   
Hemoglobin  1/39 (2.56%) 
Leukocytes (total WBC)  6/39 (15.38%) 
Neutrophils/granulocytes (ANC/AGC)  13/39 (33.33%) 
Platelets  1/39 (2.56%) 
Cardiac disorders   
Cardiac arrhythmia  1/39 (2.56%) 
Eye disorders   
Ocular/Visual - Other (Specify)  1/39 (2.56%) 
Gastrointestinal disorders   
Dysphagia (difficulty swallowing)  1/39 (2.56%) 
Hemorrhage, GI, Stomach  1/39 (2.56%) 
Hemorrhage, GI, Upper GI NOS  1/39 (2.56%) 
Hemorrhage/bleeding associated with surgery, intra-operative or postoperative  1/39 (2.56%) 
Nausea  2/39 (5.13%) 
Ulcer, GI, Duodenum  1/39 (2.56%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  2/39 (5.13%) 
Rigors/chills  1/39 (2.56%) 
Pain-Other  1/39 (2.56%) 
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1/39 (2.56%) 
Infection - Other (Specify)  1/39 (2.56%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1/39 (2.56%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)  1/39 (2.56%) 
Glucose, serum-high (hyperglycemia)  1/39 (2.56%) 
Magnesium, serum-low (hypomagnesemia)  6/39 (15.38%) 
Potassium, serum-high (hyperkalemia)  1/39 (2.56%) 
Potassium, serum-low (hypokalemia)  1/39 (2.56%) 
Weight loss  3/39 (7.69%) 
Metabolism and nutrition disorders   
Anorexia  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized  1/39 (2.56%) 
Pain, Joint  1/39 (2.56%) 
Nervous system disorders   
Syncope (fainting)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1/39 (2.56%) 
Edema, larynx  1/39 (2.56%) 
Hypoxia  1/39 (2.56%) 
Pain, Throat/pharynx/larynx  2/39 (5.13%) 
Skin and subcutaneous tissue disorders   
Rash: acne/acneiform  1/39 (2.56%) 
Rash: dermatitis associated with radiation, Chemoradiation  2/39 (5.13%) 
Rash: dermatitis associated with radiation, Radiation  3/39 (7.69%) 
Vascular disorders   
Thrombosis/thrombus/embolism  2/39 (5.13%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Head and Neck Cancer Patients
Affected / at Risk (%)
Total   39/39 (100.00%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow - Other  1/39 (2.56%) 
Febrile neutropenia (unknown origin without documented infection)(ANC <1.0 x 10^9/L)  3/39 (7.69%) 
Hemoglobin  25/39 (64.10%) 
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)  5/39 (12.82%) 
Hemorrhage/Bleeding - Other  1/39 (2.56%) 
Lymphatics - Other  1/39 (2.56%) 
Cardiac disorders   
Cardiac Arrhythmia - Other  1/39 (2.56%) 
Supraventricular and nodal arrhythmia, Atrial flutter  1/39 (2.56%) 
Ear and labyrinth disorders   
Auditory/Ear - Other  2/39 (5.13%) 
Pain, External ear  1/39 (2.56%) 
Pain, Middle ear  2/39 (5.13%) 
Tinnitus  1/39 (2.56%) 
Eye disorders   
Dry eye syndrome  1/39 (2.56%) 
Eyelid dysfunction  1/39 (2.56%) 
Ocular/Visual - Other  1/39 (2.56%) 
Gastrointestinal disorders   
Cheilitis  1/39 (2.56%) 
Constipation  14/39 (35.90%) 
Diarrhea  15/39 (38.46%) 
Dry mouth/salivary gland (xerostomia)  13/39 (33.33%) 
Dysphagia (difficulty swallowing)  31/39 (79.49%) 
Esophagitis  1/39 (2.56%) 
Gastritis (including bile reflux gastritis)  2/39 (5.13%) 
Gastrointestinal - Other  6/39 (15.38%) 
Heartburn/dyspepsia  2/39 (5.13%) 
Hemorrhage, GI, Rectum  1/39 (2.56%) 
Hemorrhoids  1/39 (2.56%) 
Mucositis/stomatitis (clinical exam), Oral cavity  26/39 (66.67%) 
Mucositis/stomatitis (functional/symptomatic), Oral cavity  9/39 (23.08%) 
Nausea  27/39 (69.23%) 
Pain, Abdomen NOS  2/39 (5.13%) 
Pain, Oral cavity  26/39 (66.67%) 
Pain, Stomach  1/39 (2.56%) 
Perforation, GI, Esophagus  1/39 (2.56%) 
Taste alteration (dysgeusia)  9/39 (23.08%) 
Vomiting  21/39 (53.85%) 
General disorders   
Edema: head and neck  2/39 (5.13%) 
Edema: limb  3/39 (7.69%) 
Fatigue (asthenia, lethargy, malaise)  36/39 (92.31%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)  12/39 (30.77%) 
Injection site reaction/extravasation changes  1/39 (2.56%) 
Pain - Other  10/39 (25.64%) 
Pain, Face  4/39 (10.26%) 
Pain, Pain NOS  3/39 (7.69%) 
Rigors/chills  4/39 (10.26%) 
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever)  4/39 (10.26%) 
Infections and infestations   
Infection - Other  3/39 (7.69%) 
Infection (documented) with Grade 3 or 4 neutrophils (ANC <1.0 x 10^9/L), Eye NOS  1/39 (2.56%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related  1/39 (2.56%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Joint  1/39 (2.56%) 
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)  1/39 (2.56%) 
Infection with unknown ANC, Mucosa  1/39 (2.56%) 
Injury, poisoning and procedural complications   
Burn  1/39 (2.56%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1/39 (2.56%) 
AST, SGOT(serum glutamic oxaloacetic transaminase)  1/39 (2.56%) 
Creatinine  3/39 (7.69%) 
Leukocytes (total WBC)  19/39 (48.72%) 
Neutrophils/granulocytes (ANC/AGC)  16/39 (41.03%) 
Platelets  9/39 (23.08%) 
Weight loss  10/39 (25.64%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  8/39 (20.51%) 
Anorexia  12/39 (30.77%) 
Calcium, serum-low (hypocalcemia)  12/39 (30.77%) 
Dehydration  4/39 (10.26%) 
Glucose, serum-high (hyperglycemia)  5/39 (12.82%) 
Magnesium, serum-high (hypermagnesemia)  1/39 (2.56%) 
Magnesium, serum-low (hypomagnesemia)  23/39 (58.97%) 
Metabolic/Laboratory - Other  2/39 (5.13%) 
Phosphate, serum-low (hypophosphatemia)  7/39 (17.95%) 
Potassium, serum-high (hyperkalemia)  2/39 (5.13%) 
Potassium, serum-low (hypokalemia)  3/39 (7.69%) 
Sodium, serum-low (hyponatremia)  8/39 (20.51%) 
Musculoskeletal and connective tissue disorders   
Arthritis (non-septic)  1/39 (2.56%) 
Musculoskeletal/Soft Tissue - Other  1/39 (2.56%) 
Pain, Back  1/39 (2.56%) 
Pain, Chest/thorax NOS  1/39 (2.56%) 
Pain, Extremity-limb  2/39 (5.13%) 
Pain, Joint  4/39 (10.26%) 
Pain, Muscle  3/39 (7.69%) 
Pain, Neck  7/39 (17.95%) 
Nervous system disorders   
Dizziness  5/39 (12.82%) 
Neurology - Other  1/39 (2.56%) 
Neuropathy: motor  2/39 (5.13%) 
Neuropathy: sensory  16/39 (41.03%) 
Pain, Head/headache  7/39 (17.95%) 
Seizure  1/39 (2.56%) 
Speech impairment (e.g., dysphasia or aphasia)  1/39 (2.56%) 
Tremor  1/39 (2.56%) 
Psychiatric disorders   
Confusion  1/39 (2.56%) 
Insomnia  4/39 (10.26%) 
Mood alteration, Agitation  1/39 (2.56%) 
Mood alteration, Anxiety  2/39 (5.13%) 
Mood alteration, Depression  3/39 (7.69%) 
Renal and urinary disorders   
Renal failure  1/39 (2.56%) 
Urinary frequency/urgency  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough  7/39 (17.95%) 
Dyspnea (shortness of breath)  1/39 (2.56%) 
Hemorrhage, pulmonary/upper respiratory, Nose  1/39 (2.56%) 
Hiccoughs (hiccups, singultus)  1/39 (2.56%) 
Mucositis/stomatitis (clinical exam), Esophagus  1/39 (2.56%) 
Mucositis/stomatitis (functional/symptomatic), Esophagus  2/39 (5.13%) 
Mucositis/stomatitis (functional/symptomatic), Trachea  1/39 (2.56%) 
Pain, Throat/pharynx/larynx  13/39 (33.33%) 
Pulmonary/Upper Respiratory - Other  1/39 (2.56%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  5/39 (12.82%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other  2/39 (5.13%) 
Dry skin  8/39 (20.51%) 
Hair loss/alopecia (scalp or body)  26/39 (66.67%) 
Pain, Skin  1/39 (2.56%) 
Rash/desquamation  16/39 (41.03%) 
Rash: acne/acneiform  19/39 (48.72%) 
Rash: dermatitis associated with radiation, Chemoradiation  8/39 (20.51%) 
Rash: dermatitis associated with radiation, Radiation  13/39 (33.33%) 
Rash: hand-foot skin reaction  1/39 (2.56%) 
Skin Ulceration  2/39 (5.13%) 
Vascular disorders   
Hypertension  3/39 (7.69%) 
Hypotension  5/39 (12.82%) 
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: Rita Johnson, Associate Director of Clinical Research Services
Organization: UPMC Cancer Centers
Phone: 412-647-8571
EMail: johnsonr1@upmc.edu
Layout table for additonal information
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00226239     History of Changes
Other Study ID Numbers: 05-003
First Submitted: September 22, 2005
First Posted: September 26, 2005
Results First Submitted: January 15, 2016
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017