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

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ClinicalTrials.gov Identifier: NCT01412229
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : July 2, 2017
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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 Drug: Cetuximab
Drug: Nab-paclitaxel
Drug: Carboplatin
Enrollment 40
Recruitment Details Subjects were recruited from 10/12/2011 through 4/24/2015.
Pre-assignment Details Sixty-seven subjects were consented to this trial. Of these, 29 were not eligible. 38 subjects were treated.
Arm/Group Title Treatment
Hide Arm/Group Description
  • 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.

Period Title: Overall Study
Started 39
Completed 38
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Treatment
Hide Arm/Group Description
  • 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 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
62
(46 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
7
  17.9%
Male
32
  82.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  12.8%
White
32
  82.1%
More than one race
0
   0.0%
Unknown or Not Reported
2
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Clinical Response Rate Following Induction Chemotherapy
Hide Description 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.
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 39
Measure Type: Count of Participants
Unit of Measure: Participants
CR
10
  25.6%
PR
20
  51.3%
SD
9
  23.1%
2.Secondary Outcome
Title Rate of Complete Response Following Induction Chemotherapy
Hide Description 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.
Time Frame Baseline evaluation to 3 weeks after induction chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 39
Measure Type: Count of Participants
Unit of Measure: Participants
10
  25.6%
3.Secondary Outcome
Title Progression Free Survival
Hide Description 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)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81
(64 to 90)
4.Secondary Outcome
Title Objective Response Rate (CR+PR)
Hide Description 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.
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
  • nab-paclitaxel 100mg/m2
  • Carboplatin area under curve (AUC)2 (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 Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
30
  78.9%
5.Secondary Outcome
Title Complete Response Rate (CR)
Hide Description Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
10
  26.3%
6.Secondary Outcome
Title Overall Survival
Hide Description Rate of Overall Survival
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
34
  89.5%
7.Secondary Outcome
Title Number of Participants With at Least One Grade 3-4 Toxicity
Hide Description Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time Frame 9 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment on study
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 38
Measure Type: Count of Participants
Unit of Measure: Participants
17
  44.7%
8.Secondary Outcome
Title Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event
Hide Description Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received study treatment
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
rash 11
decreased neutrophil count 4
decreased white blood cells 2
fatigue 1
palmar-plantar erythrodysesthesia syndrome 1
febrile neutropenia 1
hypocalcemia 1
hypokalemia 1
anaphylaxis to C225 0
9.Secondary Outcome
Title Patient-reported Quality of Life Scores
Hide Description 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.
Time Frame screening until one year after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on treatment who returned completed questionnaires at each time point
Arm/Group Title Treatment
Hide Arm/Group Description:
  • 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 Number of Participants Analyzed 36
Median (Full Range)
Unit of Measure: FACT-HN score
Pre-Treatment Number Analyzed 36 participants
105.67
(43.33 to 142.00)
Treatment Break Number Analyzed 25 participants
117.00
(49.20 to 142.00)
7 weeks Off Treatment Number Analyzed 29 participants
94.00
(58.00 to 132.00)
1 year Off Treatment Number Analyzed 22 participants
116.00
(53.80 to 146.00)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description
  • 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.

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   13/39 (33.33%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  2/39 (5.13%)  2
Cardiac disorders   
Atrial flutter * 1  1/39 (2.56%)  1
Gastrointestinal disorders   
Anal hemorrhage * 1  1/39 (2.56%)  1
Gastritis * 1  1/39 (2.56%)  1
Gastrointestinal disorders - Other, specify * 1 [1]  1/39 (2.56%)  1
Mucositis oral * 1  2/39 (5.13%)  3
Oral pain * 1  1/39 (2.56%)  1
Vomiting * 1  1/39 (2.56%)  2
Hepatobiliary disorders   
Gallbladder obstruction * 1  1/39 (2.56%)  1
Gallbladder pain * 1  1/39 (2.56%)  1
Hepatobiliary disorders - Other, specify * 1 [2]  1/39 (2.56%)  1
Infections and infestations   
Lung infection * 1 [3]  1/39 (2.56%)  1
Skin infection * 1  1/39 (2.56%)  1
Urinary tract infection * 1  1/39 (2.56%)  1
Injury, poisoning and procedural complications   
Tracheal obstruction * 1  1/39 (2.56%)  1
Investigations   
Neutrophil count decreased * 1  2/39 (5.13%)  2
Metabolism and nutrition disorders   
Hypomagnesemia * 1  1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness * 1  1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  1/39 (2.56%)  1
Skin and subcutaneous tissue disorders   
Rash acneiform * 1  1/39 (2.56%)  1
Skin ulceration * 1  1/39 (2.56%)  1
Vascular disorders   
Hypotension * 1  1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
increased secretions in oropharynx
[2]
biliary drain
[3]
Pneumonia
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Treatment
Affected / at Risk (%) # Events
Total   39/39 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  27/39 (69.23%) 
Gastrointestinal disorders   
Constipation * 1  23/39 (58.97%) 
Diarrhea * 1  12/39 (30.77%) 
Dry Mouth * 1  7/39 (17.95%) 
Dysphagia * 1  9/39 (23.08%) 
Gastrointestinal Disorders - Other, Specify * 1 [1]  7/39 (17.95%) 
Mucositis Oral * 1  17/39 (43.59%) 
Nausea * 1  22/39 (56.41%) 
Oral Pain * 1  13/39 (33.33%) 
Vomiting * 1  14/39 (35.90%) 
General disorders   
Fatigue * 1  23/39 (58.97%) 
General Disorders And Administration Site Conditions - Other, Specify * 1 [2]  5/39 (12.82%) 
Pain * 1  14/39 (35.90%) 
Investigations   
Alanine Aminotransferase Increased * 1  10/39 (25.64%) 
Alkaline Phosphatase Increased * 1  5/39 (12.82%) 
Aspartate Aminotransferase Increased * 1  5/39 (12.82%) 
Blood Bilirubin Increased * 1  4/39 (10.26%) 
Creatinine Increased * 1  7/39 (17.95%) 
Lymphocyte Count Decreased * 1  8/39 (20.51%) 
Neutrophil Count Decreased * 1  25/39 (64.10%) 
Platelet Count Decreased * 1  12/39 (30.77%) 
Weight Loss * 1  6/39 (15.38%) 
White Blood Cell Decreased * 1  23/39 (58.97%) 
Metabolism and nutrition disorders   
Anorexia * 1  13/39 (33.33%) 
Dehydration * 1  6/39 (15.38%) 
Hyperglycemia * 1  7/39 (17.95%) 
Hypoalbuminemia * 1  5/39 (12.82%) 
Hypocalcemia * 1  4/39 (10.26%) 
Hypokalemia * 1  6/39 (15.38%) 
Hypomagnesemia * 1  24/39 (61.54%) 
Hyponatremia * 1  11/39 (28.21%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor Pain * 1  9/39 (23.08%) 
Nervous system disorders   
Dysgeusia * 1  9/39 (23.08%) 
Peripheral Sensory Neuropathy * 1  4/39 (10.26%) 
Psychiatric disorders   
Anxiety * 1  8/39 (20.51%) 
Depression * 1  4/39 (10.26%) 
Insomnia * 1  7/39 (17.95%) 
Respiratory, thoracic and mediastinal disorders   
Hoarseness * 1  4/39 (10.26%) 
Sore Throat * 1  4/39 (10.26%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  7/39 (17.95%) 
Dermatitis Radiation * 1  9/39 (23.08%) 
Rash Acneiform * 1  34/39 (87.18%) 
Rash Maculo-Papular * 1  5/39 (12.82%) 
Skin And Subcutaneous Tissue Disorders - Other, Specify * 1 [3]  6/39 (15.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
odynophagia, polydipsia, hematemesis; tracheostomy displacement, peg tube displacement
[2]
Temperature Dysregulation, Subtherapeutic dilantin level, Mouth/Throat pain, Increased oral secretions, pain to throat and oral cavity
[3]
Cellulitis at percutaneous endoscopic gastrostomy (PEG) site; fissures, excoriation at g tube site, Abdominal skin tear around CT tube, cuticle disorder
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Robin Johnson
Organization: UNC Lineberger
Phone: (919) 966-1125
EMail: Robin_V_Johnson@med.unc.edu
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01412229    
Other Study ID Numbers: LCCC1103
First Submitted: August 5, 2011
First Posted: August 9, 2011
Results First Submitted: March 29, 2017
Results First Posted: July 2, 2017
Last Update Posted: November 23, 2020