Trial Outcomes & Findings for Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer (NCT NCT00226239)

Last Updated: 2017-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Up to 36 months

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Head and Neck Cancer Patients 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.
TPE, Induction Therapy STARTED	39
TPE, Induction Therapy COMPLETED	37
TPE, Induction Therapy NOT COMPLETED	2
XPE, Definitive Therapy STARTED	37
XPE, Definitive Therapy COMPLETED	33
XPE, Definitive Therapy NOT COMPLETED	4
Maintenance Cetuximab STARTED	31
Maintenance Cetuximab COMPLETED	17
Maintenance Cetuximab NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Head and Neck Cancer Patients n=39 Participants 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.
Age, Continuous	55 years n=99 Participants
Sex: Female, Male Female	5 Participants n=99 Participants
Sex: Female, Male Male	34 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Population: 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.

Outcome measures

Outcome measures
Measure	Head and Neck Cancer Patients n=37 Participants 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
Objective Response Rate (ORR)	86 percentage of participants Interval 75.0 to 98.0

SECONDARY outcome

Timeframe: Up to 36 months

Population: 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).

Outcome measures

Outcome measures
Measure	Head and Neck Cancer Patients n=33 Participants 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
Objective Response Rate (ORR)	100 percentage of participants Interval 91.0 to 100.0

SECONDARY outcome

Timeframe: Up to 36 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Head and Neck Cancer Patients n=38 Participants 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
Progression-free Survival (PFS) two-year PFS	70 percentage of participants Interval 53.0 to 82.0
Progression-free Survival (PFS) three-year PFS	70 percentage of participants Interval 53.0 to 82.0

SECONDARY outcome

Timeframe: Up to 24 months

Population: 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.

Two-year OS is an estimated percentage of participants still living at two years after the start of study treatment.

Outcome measures

Outcome measures
Measure	Head and Neck Cancer Patients n=38 Participants 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
2-year Overall Survival (OS)	84 percentage of participants Interval 68.0 to 93.0

SECONDARY outcome

Timeframe: Up to 36 months

Population: 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.

Three-year OS is an estimated percentage of participants still living at three years after the start of study treatment.

Outcome measures

Outcome measures
Measure	Head and Neck Cancer Patients n=38 Participants 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
3-year Overall Survival (OS)	74 percentage of participants Interval 54.0 to 86.0

SECONDARY outcome

Timeframe: Pre-treatment, Post-induction, 3 months after XPE and 12 months after XPE

Population: Analysis was completed using all responses actually obtained.

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.

Outcome measures

Outcome measures
Measure	Head and Neck Cancer Patients n=30 Participants 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
Quality of Life (QOL) FACT-G Total Score Pre-treatment	77.4311 units on a scale Standard Deviation 16.56741
Quality of Life (QOL) FACT-G Total Score Post-induction	75.6303 units on a scale Standard Deviation 15.68977
Quality of Life (QOL) FACT-G Total Score 3 months after XPE	71.3864 units on a scale Standard Deviation 17.51042
Quality of Life (QOL) FACT-G Total Score 12 months after XPE	86.6702 units on a scale Standard Deviation 18.82226
Quality of Life (QOL) FACT-HN Pre-treatment	25.7000 units on a scale Standard Deviation 6.74230
Quality of Life (QOL) FACT-HN Post-induction	25.1250 units on a scale Standard Deviation 7.42332
Quality of Life (QOL) FACT-HN 3 months after XPE	19.4545 units on a scale Standard Deviation 5.01167
Quality of Life (QOL) FACT-HN 12 months after XPE	24.5263 units on a scale Standard Deviation 7.50088

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 36 months

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.

Outcome measures

Outcome data not reported

Adverse Events

Head and Neck Cancer Patients

Serious events: 32 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Head and Neck Cancer Patients n=39 participants at risk 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.
Gastrointestinal disorders Hemorrhage, GI, Upper GI NOS	2.6% 1/39
Gastrointestinal disorders Hemorrhage/bleeding associated with surgery, intra-operative or postoperative	2.6% 1/39
Gastrointestinal disorders Nausea	5.1% 2/39
Gastrointestinal disorders Ulcer, GI, Duodenum	2.6% 1/39
General disorders Fatigue (asthenia, lethargy, malaise)	5.1% 2/39
General disorders Rigors/chills	2.6% 1/39
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	2.6% 1/39
Infections and infestations Infection - Other (Specify)	2.6% 1/39
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	2.6% 1/39
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	2.6% 1/39
Investigations Glucose, serum-high (hyperglycemia)	2.6% 1/39
Investigations Magnesium, serum-low (hypomagnesemia)	15.4% 6/39
Investigations Potassium, serum-high (hyperkalemia)	2.6% 1/39
Investigations Potassium, serum-low (hypokalemia)	2.6% 1/39
Investigations Weight loss	7.7% 3/39
Metabolism and nutrition disorders Anorexia	5.1% 2/39
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized	2.6% 1/39
Musculoskeletal and connective tissue disorders Pain, Joint	2.6% 1/39
Nervous system disorders Syncope (fainting)	2.6% 1/39
General disorders Pain-Other	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Edema, larynx	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Hypoxia	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Pain, Throat/pharynx/larynx	5.1% 2/39
Skin and subcutaneous tissue disorders Rash: acne/acneiform	2.6% 1/39
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation, Chemoradiation	5.1% 2/39
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation, Radiation	7.7% 3/39
Vascular disorders Thrombosis/thrombus/embolism	5.1% 2/39
Blood and lymphatic system disorders Hemoglobin	2.6% 1/39
Blood and lymphatic system disorders Leukocytes (total WBC)	15.4% 6/39
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	33.3% 13/39
Blood and lymphatic system disorders Platelets	2.6% 1/39
Cardiac disorders Cardiac arrhythmia	2.6% 1/39
Eye disorders Ocular/Visual - Other (Specify)	2.6% 1/39
Gastrointestinal disorders Dysphagia (difficulty swallowing)	2.6% 1/39
Gastrointestinal disorders Hemorrhage, GI, Stomach	2.6% 1/39

Other adverse events

Other adverse events
Measure	Head and Neck Cancer Patients n=39 participants at risk 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.
Blood and lymphatic system disorders Blood/Bone Marrow - Other	2.6% 1/39
Blood and lymphatic system disorders Febrile neutropenia (unknown origin without documented infection)(ANC <1.0 x 10^9/L)	7.7% 3/39
Blood and lymphatic system disorders Hemoglobin	64.1% 25/39
Blood and lymphatic system disorders Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)	12.8% 5/39
Blood and lymphatic system disorders Hemorrhage/Bleeding - Other	2.6% 1/39
Blood and lymphatic system disorders Lymphatics - Other	2.6% 1/39
Cardiac disorders Cardiac Arrhythmia - Other	2.6% 1/39
Cardiac disorders Supraventricular and nodal arrhythmia, Atrial flutter	2.6% 1/39
Ear and labyrinth disorders Auditory/Ear - Other	5.1% 2/39
Ear and labyrinth disorders Pain, External ear	2.6% 1/39
Ear and labyrinth disorders Pain, Middle ear	5.1% 2/39
Ear and labyrinth disorders Tinnitus	2.6% 1/39
Eye disorders Dry eye syndrome	2.6% 1/39
Eye disorders Eyelid dysfunction	2.6% 1/39
Eye disorders Ocular/Visual - Other	2.6% 1/39
Gastrointestinal disorders Cheilitis	2.6% 1/39
Gastrointestinal disorders Constipation	35.9% 14/39
Gastrointestinal disorders Diarrhea	38.5% 15/39
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	33.3% 13/39
Gastrointestinal disorders Dysphagia (difficulty swallowing)	79.5% 31/39
Gastrointestinal disorders Esophagitis	2.6% 1/39
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	5.1% 2/39
Gastrointestinal disorders Gastrointestinal - Other	15.4% 6/39
Gastrointestinal disorders Heartburn/dyspepsia	5.1% 2/39
Gastrointestinal disorders Hemorrhage, GI, Rectum	2.6% 1/39
Gastrointestinal disorders Hemorrhoids	2.6% 1/39
Gastrointestinal disorders Mucositis/stomatitis (clinical exam), Oral cavity	66.7% 26/39
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic), Oral cavity	23.1% 9/39
Gastrointestinal disorders Nausea	69.2% 27/39
Gastrointestinal disorders Pain, Abdomen NOS	5.1% 2/39
Gastrointestinal disorders Pain, Oral cavity	66.7% 26/39
Gastrointestinal disorders Pain, Stomach	2.6% 1/39
Gastrointestinal disorders Perforation, GI, Esophagus	2.6% 1/39
Gastrointestinal disorders Taste alteration (dysgeusia)	23.1% 9/39
Gastrointestinal disorders Vomiting	53.8% 21/39
General disorders Edema: head and neck	5.1% 2/39
General disorders Edema: limb	7.7% 3/39
General disorders Fatigue (asthenia, lethargy, malaise)	92.3% 36/39
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)	30.8% 12/39
General disorders Injection site reaction/extravasation changes	2.6% 1/39
General disorders Pain - Other	25.6% 10/39
General disorders Pain, Face	10.3% 4/39
General disorders Pain, Pain NOS	7.7% 3/39
General disorders Rigors/chills	10.3% 4/39
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	10.3% 4/39
Infections and infestations Infection - Other	7.7% 3/39
Infections and infestations Infection (documented) with Grade 3 or 4 neutrophils (ANC <1.0 x 10^9/L), Eye NOS	2.6% 1/39
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related	2.6% 1/39
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Joint	2.6% 1/39
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)	2.6% 1/39
Infections and infestations Infection with unknown ANC, Mucosa	2.6% 1/39
Injury, poisoning and procedural complications Burn	2.6% 1/39
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	2.6% 1/39
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	2.6% 1/39
Investigations Creatinine	7.7% 3/39
Investigations Leukocytes (total WBC)	48.7% 19/39
Investigations Neutrophils/granulocytes (ANC/AGC)	41.0% 16/39
Investigations Platelets	23.1% 9/39
Investigations Weight loss	25.6% 10/39
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	20.5% 8/39
Metabolism and nutrition disorders Anorexia	30.8% 12/39
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	30.8% 12/39
Metabolism and nutrition disorders Dehydration	10.3% 4/39
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	12.8% 5/39
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	2.6% 1/39
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	59.0% 23/39
Metabolism and nutrition disorders Metabolic/Laboratory - Other	5.1% 2/39
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	17.9% 7/39
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	5.1% 2/39
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	7.7% 3/39
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	20.5% 8/39
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	2.6% 1/39
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	2.6% 1/39
Musculoskeletal and connective tissue disorders Pain, Back	2.6% 1/39
Musculoskeletal and connective tissue disorders Pain, Chest/thorax NOS	2.6% 1/39
Musculoskeletal and connective tissue disorders Pain, Extremity-limb	5.1% 2/39
Musculoskeletal and connective tissue disorders Pain, Joint	10.3% 4/39
Musculoskeletal and connective tissue disorders Pain, Muscle	7.7% 3/39
Musculoskeletal and connective tissue disorders Pain, Neck	17.9% 7/39
Nervous system disorders Dizziness	12.8% 5/39
Nervous system disorders Neurology - Other	2.6% 1/39
Nervous system disorders Neuropathy: motor	5.1% 2/39
Nervous system disorders Neuropathy: sensory	41.0% 16/39
Nervous system disorders Pain, Head/headache	17.9% 7/39
Nervous system disorders Seizure	2.6% 1/39
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	2.6% 1/39
Nervous system disorders Tremor	2.6% 1/39
Psychiatric disorders Confusion	2.6% 1/39
Psychiatric disorders Insomnia	10.3% 4/39
Psychiatric disorders Mood alteration, Agitation	2.6% 1/39
Psychiatric disorders Mood alteration, Anxiety	5.1% 2/39
Psychiatric disorders Mood alteration, Depression	7.7% 3/39
Renal and urinary disorders Renal failure	2.6% 1/39
Renal and urinary disorders Urinary frequency/urgency	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Cough	17.9% 7/39
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory, Nose	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (clinical exam), Esophagus	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (functional/symptomatic), Esophagus	5.1% 2/39
Respiratory, thoracic and mediastinal disorders Mucositis/stomatitis (functional/symptomatic), Trachea	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Pain, Throat/pharynx/larynx	33.3% 13/39
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	2.6% 1/39
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	12.8% 5/39
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	5.1% 2/39
Skin and subcutaneous tissue disorders Dry skin	20.5% 8/39
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	66.7% 26/39
Skin and subcutaneous tissue disorders Pain, Skin	2.6% 1/39
Skin and subcutaneous tissue disorders Rash/desquamation	41.0% 16/39
Skin and subcutaneous tissue disorders Rash: acne/acneiform	48.7% 19/39
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation, Chemoradiation	20.5% 8/39
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation, Radiation	33.3% 13/39
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	2.6% 1/39
Skin and subcutaneous tissue disorders Skin Ulceration	5.1% 2/39
Vascular disorders Hypertension	7.7% 3/39
Vascular disorders Hypotension	12.8% 5/39

Additional Information

Rita Johnson, Associate Director of Clinical Research Services

UPMC Cancer Centers

Phone: 412-647-8571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place