Trial Outcomes & Findings for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (NCT NCT01412229)

Last Updated: 2020-11-23

Results Overview

Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

9 weeks

Results posted on

2020-11-23

Participant Flow

Subjects were recruited from 10/12/2011 through 4/24/2015.

Sixty-seven subjects were consented to this trial. Of these, 29 were not eligible. 38 subjects were treated.

Participant milestones

Participant milestones
Measure	Treatment * nab-paclitaxel 100mg/m2 * Carboplatin Area under the Curve (AUC2) (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Overall Study STARTED	39
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment * nab-paclitaxel 100mg/m2 * Carboplatin Area under the Curve (AUC2) (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Overall Study Physician Decision	1

Baseline Characteristics

Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=39 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Age, Continuous	62 years n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	32 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	39 participants n=93 Participants

PRIMARY outcome

Timeframe: 9 weeks

Outcome measures

Outcome measures
Measure	Treatment n=39 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Clinical Response Rate Following Induction Chemotherapy SD	9 Participants
Clinical Response Rate Following Induction Chemotherapy CR	10 Participants
Clinical Response Rate Following Induction Chemotherapy PR	20 Participants

SECONDARY outcome

Timeframe: Baseline evaluation to 3 weeks after induction chemotherapy

Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.

Outcome measures

Outcome measures
Measure	Treatment n=39 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Rate of Complete Response Following Induction Chemotherapy	10 Participants

SECONDARY outcome

Timeframe: 1 year

Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for one year)

Outcome measures

Outcome measures
Measure	Treatment n=39 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Progression Free Survival	81 percentage of participants Interval 64.0 to 90.0

SECONDARY outcome

Timeframe: 20 weeks

Population: Patients who completed treatment

Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment n=38 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Objective Response Rate (CR+PR)	30 Participants

SECONDARY outcome

Timeframe: 20 weeks

Population: Patients who completed treatment

Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation

Outcome measures

Outcome measures
Measure	Treatment n=38 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Complete Response Rate (CR)	10 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Patients who completed treatment

Rate of Overall Survival

Outcome measures

Outcome measures
Measure	Treatment n=38 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Overall Survival	34 Participants

SECONDARY outcome

Timeframe: 9 Weeks

Population: Patients who received treatment on study

Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Outcome measures
Measure	Treatment n=38 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Number of Participants With at Least One Grade 3-4 Toxicity	17 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Patients who received study treatment

Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Outcome measures
Measure	Treatment n=38 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event rash	11 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event decreased neutrophil count	4 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event decreased white blood cells	2 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event fatigue	1 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event palmar-plantar erythrodysesthesia syndrome	1 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event febrile neutropenia	1 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event hypocalcemia	1 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event hypokalemia	1 participants
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event anaphylaxis to C225	0 participants

SECONDARY outcome

Timeframe: screening until one year after treatment

Population: All patients on treatment who returned completed questionnaires at each time point

Functional Assessment of Cancer Therapy - Head \& Neck (FACT-HN) is the FACT-G and a 12 item head and neck cancer specific subscale completed at screening (Screening), 3 weeks post induction chemotherapy (Treatment Break), 7 weeks post concomitant chemoradiotherapy (7 weeks Off Treatment), one year post off-treatment (1 year Off Treatment). The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4 (resulting in potential total scores between 0 and 156). Higher scores represent better QOL.

Outcome measures

Outcome measures
Measure	Treatment n=36 Participants * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Patient-reported Quality of Life Scores Treatment Break	117.00 FACT-HN score Interval 49.2 to 142.0
Patient-reported Quality of Life Scores 7 weeks Off Treatment	94.00 FACT-HN score Interval 58.0 to 132.0
Patient-reported Quality of Life Scores 1 year Off Treatment	116.00 FACT-HN score Interval 53.8 to 146.0
Patient-reported Quality of Life Scores Pre-Treatment	105.67 FACT-HN score Interval 43.33 to 142.0

Adverse Events

Treatment

Serious events: 13 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=39 participants at risk * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Gastrointestinal disorders Anal hemorrhage	2.6% 1/39 • Number of events 1 • 24 weeks
Cardiac disorders Atrial flutter	2.6% 1/39 • Number of events 1 • 24 weeks
Blood and lymphatic system disorders Febrile neutropenia	5.1% 2/39 • Number of events 2 • 24 weeks
Hepatobiliary disorders Gallbladder obstruction	2.6% 1/39 • Number of events 1 • 24 weeks
Hepatobiliary disorders Gallbladder pain	2.6% 1/39 • Number of events 1 • 24 weeks
Gastrointestinal disorders Gastritis	2.6% 1/39 • Number of events 1 • 24 weeks
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.6% 1/39 • Number of events 1 • 24 weeks
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.6% 1/39 • Number of events 1 • 24 weeks
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	2.6% 1/39 • Number of events 1 • 24 weeks
Metabolism and nutrition disorders Hypomagnesemia	2.6% 1/39 • Number of events 1 • 24 weeks
Vascular disorders Hypotension	2.6% 1/39 • Number of events 1 • 24 weeks
Infections and infestations Lung infection	2.6% 1/39 • Number of events 1 • 24 weeks
Gastrointestinal disorders Mucositis oral	5.1% 2/39 • Number of events 3 • 24 weeks
Investigations Neutrophil count decreased	5.1% 2/39 • Number of events 2 • 24 weeks
Gastrointestinal disorders Oral pain	2.6% 1/39 • Number of events 1 • 24 weeks
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.6% 1/39 • Number of events 1 • 24 weeks
Skin and subcutaneous tissue disorders Rash acneiform	2.6% 1/39 • Number of events 1 • 24 weeks
Infections and infestations Skin infection	2.6% 1/39 • Number of events 1 • 24 weeks
Skin and subcutaneous tissue disorders Skin ulceration	2.6% 1/39 • Number of events 1 • 24 weeks
Injury, poisoning and procedural complications Tracheal obstruction	2.6% 1/39 • Number of events 1 • 24 weeks
Infections and infestations Urinary tract infection	2.6% 1/39 • Number of events 1 • 24 weeks
Gastrointestinal disorders Vomiting	2.6% 1/39 • Number of events 2 • 24 weeks

Other adverse events

Other adverse events
Measure	Treatment n=39 participants at risk * nab-paclitaxel 100mg/m2 * Carboplatin AUC2 (IV) * Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks Cetuximab: Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. Nab-paclitaxel: Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. Carboplatin: Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Investigations Alanine Aminotransferase Increased	25.6% 10/39 • 24 weeks
Investigations Alkaline Phosphatase Increased	12.8% 5/39 • 24 weeks
Skin and subcutaneous tissue disorders Alopecia	17.9% 7/39 • 24 weeks
Blood and lymphatic system disorders Anemia	69.2% 27/39 • 24 weeks
Metabolism and nutrition disorders Anorexia	33.3% 13/39 • 24 weeks
Psychiatric disorders Anxiety	20.5% 8/39 • 24 weeks
Investigations Aspartate Aminotransferase Increased	12.8% 5/39 • 24 weeks
Investigations Blood Bilirubin Increased	10.3% 4/39 • 24 weeks
Gastrointestinal disorders Constipation	59.0% 23/39 • 24 weeks
Investigations Creatinine Increased	17.9% 7/39 • 24 weeks
Metabolism and nutrition disorders Dehydration	15.4% 6/39 • 24 weeks
Psychiatric disorders Depression	10.3% 4/39 • 24 weeks
Skin and subcutaneous tissue disorders Dermatitis Radiation	23.1% 9/39 • 24 weeks
Gastrointestinal disorders Diarrhea	30.8% 12/39 • 24 weeks
Gastrointestinal disorders Dry Mouth	17.9% 7/39 • 24 weeks
Nervous system disorders Dysgeusia	23.1% 9/39 • 24 weeks
Gastrointestinal disorders Dysphagia	23.1% 9/39 • 24 weeks
General disorders Fatigue	59.0% 23/39 • 24 weeks
Gastrointestinal disorders Gastrointestinal Disorders - Other, Specify	17.9% 7/39 • 24 weeks
General disorders General Disorders And Administration Site Conditions - Other, Specify	12.8% 5/39 • 24 weeks
Respiratory, thoracic and mediastinal disorders Hoarseness	10.3% 4/39 • 24 weeks
Metabolism and nutrition disorders Hyperglycemia	17.9% 7/39 • 24 weeks
Metabolism and nutrition disorders Hypoalbuminemia	12.8% 5/39 • 24 weeks
Metabolism and nutrition disorders Hypocalcemia	10.3% 4/39 • 24 weeks
Metabolism and nutrition disorders Hypokalemia	15.4% 6/39 • 24 weeks
Metabolism and nutrition disorders Hypomagnesemia	61.5% 24/39 • 24 weeks
Metabolism and nutrition disorders Hyponatremia	28.2% 11/39 • 24 weeks
Psychiatric disorders Insomnia	17.9% 7/39 • 24 weeks
Investigations Lymphocyte Count Decreased	20.5% 8/39 • 24 weeks
Gastrointestinal disorders Mucositis Oral	43.6% 17/39 • 24 weeks
Gastrointestinal disorders Nausea	56.4% 22/39 • 24 weeks
Investigations Neutrophil Count Decreased	64.1% 25/39 • 24 weeks
Gastrointestinal disorders Oral Pain	33.3% 13/39 • 24 weeks
General disorders Pain	35.9% 14/39 • 24 weeks
Nervous system disorders Peripheral Sensory Neuropathy	10.3% 4/39 • 24 weeks
Investigations Platelet Count Decreased	30.8% 12/39 • 24 weeks
Skin and subcutaneous tissue disorders Rash Acneiform	87.2% 34/39 • 24 weeks
Skin and subcutaneous tissue disorders Rash Maculo-Papular	12.8% 5/39 • 24 weeks
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other, Specify	15.4% 6/39 • 24 weeks
Respiratory, thoracic and mediastinal disorders Sore Throat	10.3% 4/39 • 24 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	23.1% 9/39 • 24 weeks
Gastrointestinal disorders Vomiting	35.9% 14/39 • 24 weeks
Investigations Weight Loss	15.4% 6/39 • 24 weeks
Investigations White Blood Cell Decreased	59.0% 23/39 • 24 weeks

Additional Information

Robin Johnson

UNC Lineberger

Phone: (919) 966-1125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER