Squamous Cell Carcinoma of the Head and Neck
Conditions
Brief summary
This phase two trial will determine the tumor response rate at the primary site and at involved regional nodes to two cycles of an IC regimen of weekly Abraxane and cetuximab given in combination with cisplatin and 5-FU in patients with local regionally advanced HNSCC.
Detailed description
Primary objective: To determine the clinical CR rate (CR-p) at the primary tumor site to an IC regimen of weekly Abraxane and cetuximab with CF (ACCF) given for two cycles (over 6 weeks) in patients with locally advanced non-metastatic HNSCC. The assessment of primary tumor site response will be performed by the treating physician by careful clinical examination using WHO criteria. Radiographic studies will also be performed to assess primary tumor site response but will be used primarily to confirm lack of disease progression that may not be detected based on clinical examination alone. The secondary objectives include: * Document the clinical PR rate (PR-p) at the primary tumor site with this IC regimen * Document the clinical CR and PR rates at the involved regional nodes (CR-n and PR-n) with this IC regimen * Document the clinical overall CR rate (CR-o) (defined as achievement of a CR at the primary tumor site and at the involved regional nodes) and the clinical overall PR rate (PR-o) with this IC regimen * Document the CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates by FDG uptake on PET scan after this IC regimen * Document radiographic CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates as assessed by conventional CT scan using RECIST criteria after this IC regimen. * Correlate primary tumor site, nodal and overall tumor response rates based on WHO criteria of assessment with that based on CT scan and FDG-PET/CT. * Document and quantify SPARC expression by IHC in primary tumor tissue obtained at baseline in each patient and attempt to correlate these results with primary tumor site response to ACCF. * Document and grade AE's with this IC regimen with a pre-planned safety analysis after the first ten patients have completed the IC regimen. * Determine the overall survival (OS), disease-free survival (DFS), and progression-free survival (PFS) of this patient population.
Interventions
DRUGAbraxane
100 mg/m2 IVPB, Day 1, 8 and 15 of cycles 1, 2, and 3
DRUGCetuximab
400 mg/m2 IVPB, Day 1, cycle 1
DRUGCisplatin
75 mg/m2 IVPB Day 1, cycles 1, 2 and 3
DRUG5-FU
750 mg/m2 CIVI Day 1, 2 and 3, cycles 1, 2 and 3
RADIATIONRadiation (Post induction)
Monday-Friday, weeks 1-7
Sponsors
Celgene Corporation
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion * Selected Stages 3 and 4a/b HNSCC: All patients must have T2-T4 primary tumors. Patients with T1 tumors will be excluded. Although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible. * Oropharynx, hypopharynx, larynx, and oral cavity sub-sites only. Patients with nasopharyngeal, sinus and other sub-sites of the head and neck, or unknown primary SCC of the head and neck will NOT be eligible. * Age ≥18 years * Signed informed consent. * ECOG Performance Status (PS) of 0-2 (Appendix 1). * Adequate vital organ function (serum creatinine \< 1.8 mg/dl, total bilirubin \</= 1.5 mg/dl, ALT and AST \</= 2.5 x ULN, alkaline phosphatase \</= 2.5 x ULN) and hematopoietic function (ANC \>/= 1500/ul, Platelets \> 100,000/ul, HGB \> 9.0 g/dl). * Patients with reproductive potential must use an effective method of contraception to avoid pregnancy for the duration of the trial and for three months after completing treatment. * If female of childbearing potential, the patient must have a negative pregnancy test.
Exclusion criteria
* Peripheral neuropathy \> Grade 1. * Prior chemotherapy, EGFR targeted therapy or radiation therapy for HNSCC. * History of prior invasive malignancy diagnosed within the last three years other than local stage non-melanoma skin cancer. * Be taking cimetidine or allopurinol. Patients must discontinue taking the medication for one week before receiving treatment with Abraxane. * Be taking cimetidine or allopurinol. Patients must discontinue taking the medication for one week before receiving treatment with Abraxane.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Complete Response Rate at the Primary Tumor | post-2 cycles of induction (approximately 42 days from start of treatment) | Clinical exam included laryngoscopy in office or operating room. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Partial Response Rate at the Primary Tumor | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Clinical exam included laryngoscopy in office or operating room. Partial response rate (PR) defined as 50% to 94% decrease in tumor size. |
| Clinical Complete and Partial Response Rates to the Involved Regional Nodes | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. |
| Clinical Overall Complete and Partial Response Rates | post-2 cycles of induction therapy (approximately 42 days) | Clinical exam included laryngoscopy in office or operating room. Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size. |
| Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. |
| Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. |
| Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. |
| Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. |
| Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter. |
| Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles. |
| Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. |
| Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields |
| Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields |
| Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = intensity of SPARC staining in tumor |
| Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | SPARC expression = intensity of SPARC staining in tumor |
| Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | completion of the first 10 patients induction chemotherapy | — |
| Overall Survival | 10 years from completion of treatment | Time from diagnosis to death or to last follow-up alive. |
| Disease Free Survival | 10 years from completion of treatment | Time from complete response to death from any cause, to disease progression or to last follow-up alive. |
| Time to Progression | 10 years from completion of treatment | Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive. |
| Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Complete and Partial Response Rates by FDG Uptake on PET Scan | post-2 cycles of induction therapy (approximately 42 days from start of treatment) | Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions. |
Countries
United States
Participant flow
Recruitment details
Recruitment was open from 12/19/08-10/18/11 at the Siteman Cancer Center (a medical clinic).
Participants by arm
| Arm | Count |
|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab Induction chemotherapy:
Abraxane 100 mg/m2 IVPB, Day 1, 8, and 15 of cycles 1, 2, and 3. Cetuximab 400 mg/m2 IVPB, Day 1, cycle 1. Cetuximab 250 mg/m2 IVPB, Day 8 and 15 cycle 1, 2 and 3. Cisplatin 75 mg/m2 IVPB, Day 1, cycles 1, 2, and 3. 5-FU 750 mg/m2 CIVI, Day 1, 2 and 3, cycles 1, 2, and 3.
Post-Induction:
Radiation - Monday-Friday weeks 1-7 with concurrent Cisplatin 100 mg/m2 IVPB on radiation day 1, 22, and 42 or Cetuximab 250 mg/m2 IVPB weekly Q8W. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Definitive Treatment | Physician Decision | 1 |
| Induction | Death | 1 |
Baseline characteristics
| Characteristic | Induction Chemo + RT + Cisplatin or Cetuximab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age, Continuous | 54.5 years |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 19 / 30 |
Outcome results
Primary
Clinical Complete Response Rate at the Primary Tumor
Clinical exam included laryngoscopy in office or operating room. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size.
Time frame: post-2 cycles of induction (approximately 42 days from start of treatment)
Population: All patients who completed 2 cycles of induction therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Clinical Complete Response Rate at the Primary Tumor | 16 participants |
Secondary
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Time frame: completion of the first 10 patients induction chemotherapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Allergic reaction/hypersensitivity | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Other allergic reaction:cipro | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Other allergic reaction:hives | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Hypotension | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | INR | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Fatigue | 10 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Alopecia | 5 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Chelitis | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Dry skin | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Rash | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Rash:acneiform | 7 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Rash:penile (unconfirmed HSV) | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Anorexia | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Colitis | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Constipation | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Dehydration | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Dental:teeth | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Diarrhea | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Hemorrhoids | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Nausea | 9 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Taste alteration | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Vomiting | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Other:soft stools | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Hemoglobin | 8 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Leukocytes (WBC) | 8 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Lymphopenia | 8 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Neutrophils (ANC) | 8 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Platelets | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Hemmorrhage:nose | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Alkaline phosphatase | 3 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | SGPT (ALT) | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Infection other:sinus infection | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Edema:limb | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Albumin, low | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Calcium, low | 5 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Magnesium, low | 4 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Potassium, low | 3 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Potassium, high | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Sodium, low | 3 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Phosphorus | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Dizziness | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Mood alteration:anger | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Neuropathy:sensory (peripheral) | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Vision-photophobia | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Pain:thigh | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Pain:tumor pain | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Hiccoughs (hiccups) | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Obstruction/stenosis of airway:trachea | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Creatinine | 4 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | GFR | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Renal failure | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis | Thrombosis/thrombus/embolism | 1 participants |
Secondary
Clinical Complete and Partial Response Rates to the Involved Regional Nodes
Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Twelve patients were not evaluable because of initial absence of nodal disease on clinical exam.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Clinical Complete and Partial Response Rates to the Involved Regional Nodes | Complete response | 11 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Clinical Complete and Partial Response Rates to the Involved Regional Nodes | Partial response | 7 participants |
Secondary
Clinical Overall Complete and Partial Response Rates
Clinical exam included laryngoscopy in office or operating room. Clinical exam consisted of physical exam of neck in office. Complete response rate includes complete response (CR) which is defined as 100% decrease in tumor size and it also includes near complete response (near CR) defined as 95-99% decrease in tumor size. Partial response rate defined as 50% to 94% decrease in tumor size.
Time frame: post-2 cycles of induction therapy (approximately 42 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Clinical Overall Complete and Partial Response Rates | Overall complete response | 13 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Clinical Overall Complete and Partial Response Rates | Overall partial response | 17 participants |
Secondary
Clinical Partial Response Rate at the Primary Tumor
Clinical exam included laryngoscopy in office or operating room. Partial response rate (PR) defined as 50% to 94% decrease in tumor size.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Participants who completed 2 cycles of induction therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Clinical Partial Response Rate at the Primary Tumor | 14 participants |
Secondary
Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan
Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Five patients were not evaluable for this outcome because these patients did not have any involved lymph nodes that could be measured.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | Complete response | 9 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan | Partial response | 14 participants |
Secondary
Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan
Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Two patients were not evaluable for this outcome. One patient's insurance company denied coverage for the PET scan so the PET scan was not performed. The other patient only had neck nodes that were clearly measurable on the PET scan, the primary site could not be measured on the PET scan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | Complete response | 9 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan | Partial response | 17 participants |
Secondary
Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT
In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: 12 patients were not evaluable for VSR because they did not have nodal disease. 6 patients were not evaluable for CT scan because 5 patients did not have nodal disease and 1 patient didn't have measurable nodal disease. 5 patients were not evaluable for PET because 5 patients did not have nodal disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 39 percentage of participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 61 percentage of participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 0 percentage of participants |
| CT Scan | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 48 percentage of participants |
| CT Scan | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 30 percentage of participants |
| CT Scan | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 22 percentage of participants |
| FDG-PET/CT | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 36 percentage of participants |
| FDG-PET/CT | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 8 percentage of participants |
| FDG-PET/CT | Correlate Nodal Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 56 percentage of participants |
Secondary
Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT
In the future, primary tumor site, nodal, and overall tumor response by visual categorical response (CR-x or PR-x = yes or no) will be compared with response based on CT scan (CR-x or PR-x = yes or no) using a test for difference in paired, binary values (e.g., McNemar's test). Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. At this point, we are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles of induction.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: 1 patient was not evaluable for CT scan because the primary site could not be clearly measured and was noted as non-target lesion. 1 patient was not evaluable for PET scan because the patient's insurance company denied coverage.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 57 percentage of participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 43 percentage of participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 0 percentage of participants |
| CT Scan | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 50 percentage of participants |
| CT Scan | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 14 percentage of participants |
| CT Scan | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 36 percentage of participants |
| FDG-PET/CT | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 24 percentage of participants |
| FDG-PET/CT | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 10 percentage of participants |
| FDG-PET/CT | Correlate Overall Tumor Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 66 percentage of participants |
Secondary
Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT
In the future, primary tumor site, nodal, and OTR by VCR (CR-x or PR-x = Y or N) will be compared with response based on CT scan (CR-x or PR-x = Y or N) using a test for difference in paired, binary values. Median standardized uptake value of FDG measured by PET/CT will be compared among those with or without response (CR-x or PR-x) using nonparametric Wilcoxon-Mann-Whitney tests. We are releasing results based on comparing actual responses from visual categorical response, CT scan, and FDG-PET/CT scan after 2 cycles.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: 2 patients were not evaluable for the CT Scan of this outcome because they did not have primary disease that could be measured per RECIST. 2 patients were not evaluable for PET scan of this outcome because one patient's insurance company denied coverage and the other patient did not have primary site disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 47 percentage of participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 53 percentage of participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 0 percentage of participants |
| CT Scan | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 41 percentage of participants |
| CT Scan | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 33 percentage of participants |
| CT Scan | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 26 percentage of participants |
| FDG-PET/CT | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Complete Response | 32 percentage of participants |
| FDG-PET/CT | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Stable Disease/Progressive Disease | 7 percentage of participants |
| FDG-PET/CT | Correlate Primary Tumor Site Response Rates Based on Visual Categorical Criteria of Assessment With That Based on CT Scan and FDG-PET/CT | Partial Response | 61 percentage of participants |
Secondary
Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy
SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Patients who had available tumor tissue for SPARC testing and were complete responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | Negative staining | 14 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | 1+ staining (0%-24%) | 0 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | 2+ staining (25%-49%) | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | 3+ staining (50%-74%) | 0 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | 4+ staining (75%-100%) | 0 participants |
Secondary
Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy
SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Patients who had available tumor tissue for SPARC testing and were partial responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | Negative staining | 6 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | 1+ staining (0%-24%) | 4 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | 2+ staining (25%-49%) | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | 3+ staining (50%-74%) | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | 4+ staining (75%-100%) | 0 participants |
Secondary
Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy
SPARC expression = intensity of SPARC staining in tumor
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Patients who had available tumor tissue for SPARC testing and were complete responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | Negative staining | 14 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | 1+ staining (weak) | 0 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | 2+ staining (moderate) | 1 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Complete Response Rate to Induction Chemotherapy | 3+ staining (strong) | 0 participants |
Secondary
Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy
SPARC expression = intensity of SPARC staining in tumor
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Patients who had available tumor tissue for SPARC testing and were partial responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | Negative staining | 6 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | 1+ staining (weak) | 2 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | 2+ staining (moderate) | 4 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Correlate SPARC Expression (Intensity of Staining) by Immunohistochemistry (IHC) in Baseline Primary Tumor Tissue With Primary Tumor Site Partial Response Rate to Induction Chemotherapy | 3+ staining (strong) | 1 participants |
Secondary
Disease Free Survival
Time from complete response to death from any cause, to disease progression or to last follow-up alive.
Time frame: 10 years from completion of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Disease Free Survival | 93.529 months | Standard Error 3.462 |
Secondary
Overall Survival
Time from diagnosis to death or to last follow-up alive.
Time frame: 10 years from completion of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Overall Survival | 83.960 months | Standard Error 5.384 |
Secondary
Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria
Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Six patients were not evaluable for this outcome. Five of these patients did not have any involved lymph nodes available to evaluate. The sixth patient did not have involved lymph nodes that were clearly measurable by CT and RECIST.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response | 7 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria | Partial response | 12 participants |
Secondary
Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria
Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: Two patients were not evaluable for this outcome. The first patient didn't have primary site disease that could be measured by RECIST. The second patient had primary site disease but it could not be clearly measured by CT. This disease was noted as a non-target lesion as present at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria | Complete response | 10 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria | Partial response | 11 participants |
Secondary
Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria
Complete response rate per RECIST criteria is defined as disappearance of all target lesions. Partial response rate per RECIST criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: One patient was not evaluable for this outcome. This patient had primary site disease that could not be clearly measured per CT and was listed as a non-target lesion.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria | Overall complete response | 4 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria | Overall partial response | 14 participants |
Secondary
Time to Progression
Time from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive.
Time frame: 10 years from completion of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Time to Progression | 38.675 months | Standard Error 1.485 |
Other Pre-specified
Overall Complete and Partial Response Rates by FDG Uptake on PET Scan
Complete response rate defined as complete resolution of the metabolically active primary tumor. Partial response rate defined as 20% or greater decrease in maximum SUV \[SUV g/ml) = ROI activity (mCi/ml) / (injected dose (mCi/body weight(g))\] from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.
Time frame: post-2 cycles of induction therapy (approximately 42 days from start of treatment)
Population: One patient was not evaluable for this outcome. This patient's insurance company denied coverage for the post-cycle 2 timepoint and because of this was not included in this overall response rate for PET scan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Induction Chemo + RT + Cisplatin or Cetuximab | Overall Complete and Partial Response Rates by FDG Uptake on PET Scan | Overall partial response | 19 participants |
| Induction Chemo + RT + Cisplatin or Cetuximab | Overall Complete and Partial Response Rates by FDG Uptake on PET Scan | Overall complete response | 7 participants |