Trial Outcomes & Findings for Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer (NCT NCT00736944)
NCT ID: NCT00736944
Last Updated: 2020-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
post-2 cycles of induction (approximately 42 days from start of treatment)
Results posted on
2020-09-09
Participant Flow
Recruitment was open from 12/19/08-10/18/11 at the Siteman Cancer Center (a medical clinic).
Participant milestones
| Measure |
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.
|
|---|---|
|
Induction
STARTED
|
30
|
|
Induction
COMPLETED
|
29
|
|
Induction
NOT COMPLETED
|
1
|
|
Definitive Treatment
STARTED
|
29
|
|
Definitive Treatment
COMPLETED
|
28
|
|
Definitive Treatment
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Induction
Death
|
1
|
|
Definitive Treatment
Physician Decision
|
1
|
Baseline Characteristics
Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: post-2 cycles of induction (approximately 42 days from start of treatment)Population: All patients who completed 2 cycles of induction therapy.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Clinical Complete Response Rate at the Primary Tumor
|
16 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: post-2 cycles of induction therapy (approximately 42 days from start of treatment)Population: Participants who completed 2 cycles of induction therapy
Clinical exam included laryngoscopy in office or operating room. Partial response rate (PR) defined as 50% to 94% decrease in tumor size.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Clinical Partial Response Rate at the Primary Tumor
|
14 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=18 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Clinical Complete and Partial Response Rates to the Involved Regional Nodes
Complete response
|
11 participants
|
—
|
—
|
|
Clinical Complete and Partial Response Rates to the Involved Regional Nodes
Partial response
|
7 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Clinical Overall Complete and Partial Response Rates
Overall complete response
|
13 participants
|
—
|
—
|
|
Clinical Overall Complete and Partial Response Rates
Overall partial response
|
17 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=28 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan
Complete response
|
9 participants
|
—
|
—
|
|
Complete and Partial Response Rates of Primary Tumor by FDG Uptake on PET Scan
Partial response
|
17 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=25 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan
Complete response
|
9 participants
|
—
|
—
|
|
Complete and Partial Response Rates of Involved Lymph Nodes by FDG Uptake on PET Scan
Partial response
|
14 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=28 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria
Complete response
|
10 participants
|
—
|
—
|
|
Radiographic Complete and Partial Response Rates of Primary Tumor as Assessed by Conventional CT Scan Using RECIST Criteria
Partial response
|
11 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=24 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria
Complete response
|
7 participants
|
—
|
—
|
|
Radiographic Complete and Partial Response Rates of Involved Lymph Nodes as Assessed by Conventional CT Scan Using RECIST Criteria
Partial response
|
12 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=29 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria
Overall complete response
|
4 participants
|
—
|
—
|
|
Radiographic Overall Complete and Partial Response Rates as Assessed by Conventional CT Scan Using RECIST Criteria
Overall partial response
|
14 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
n=28 Participants
|
FDG-PET/CT
n=28 Participants
|
|---|---|---|---|
|
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
|
33 percentage of participants
|
32 percentage of participants
|
|
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
|
41 percentage of participants
|
61 percentage of participants
|
|
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
|
26 percentage of participants
|
7 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=18 Participants
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.
|
CT Scan
n=24 Participants
|
FDG-PET/CT
n=25 Participants
|
|---|---|---|---|
|
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
|
30 percentage of participants
|
36 percentage of participants
|
|
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
|
48 percentage of participants
|
56 percentage of participants
|
|
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
|
22 percentage of participants
|
8 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
n=29 Participants
|
FDG-PET/CT
n=29 Participants
|
|---|---|---|---|
|
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
|
14 percentage of participants
|
24 percentage of participants
|
|
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
|
50 percentage of participants
|
66 percentage of participants
|
|
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
|
36 percentage of participants
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=15 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: 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.
SPARC expression = Proportion of tumor cells SPARC-positive in 10 high-power fields
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=13 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: 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.
SPARC expression = intensity of SPARC staining in tumor
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=15 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: 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.
SPARC expression = intensity of SPARC staining in tumor
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=13 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: completion of the first 10 patients induction chemotherapyOutcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=10 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Infection other:sinus infection
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Allergic reaction/hypersensitivity
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Other allergic reaction:cipro
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Other allergic reaction:hives
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Hypotension
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
INR
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Fatigue
|
10 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Alopecia
|
5 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Chelitis
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Dry skin
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Rash
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Rash:acneiform
|
7 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Rash:penile (unconfirmed HSV)
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Anorexia
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Colitis
|
2 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Constipation
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Dehydration
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Dental:teeth
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Diarrhea
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Hemorrhoids
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Nausea
|
9 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Taste alteration
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Vomiting
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Other:soft stools
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Hemoglobin
|
8 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Leukocytes (WBC)
|
8 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Lymphopenia
|
8 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Neutrophils (ANC)
|
8 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Platelets
|
2 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Hemmorrhage:nose
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Alkaline phosphatase
|
3 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
SGPT (ALT)
|
2 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Edema:limb
|
2 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Albumin, low
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Calcium, low
|
5 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Magnesium, low
|
4 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Potassium, low
|
3 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Potassium, high
|
2 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Sodium, low
|
3 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Phosphorus
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Dizziness
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Mood alteration:anger
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Neuropathy:sensory (peripheral)
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Vision-photophobia
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Pain:thigh
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Pain:tumor pain
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Hiccoughs (hiccups)
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Obstruction/stenosis of airway:trachea
|
2 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Creatinine
|
4 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
GFR
|
2 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Renal failure
|
1 participants
|
—
|
—
|
|
Adverse Events Experienced During Induction Chemotherapy in the First Ten Patients for a Pre-planned Safety Analysis
Thrombosis/thrombus/embolism
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 years from completion of treatmentTime from diagnosis to death or to last follow-up alive.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Overall Survival
|
83.960 months
Standard Error 5.384
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 years from completion of treatmentTime from complete response to death from any cause, to disease progression or to last follow-up alive.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Disease Free Survival
|
93.529 months
Standard Error 3.462
|
—
|
—
|
SECONDARY outcome
Timeframe: 10 years from completion of treatmentTime from initiation of induction chemotherapy to death due to disease progression, to disease progression, or to last follow-up alive.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Time to Progression
|
38.675 months
Standard Error 1.485
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=29 Participants
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.
|
CT Scan
|
FDG-PET/CT
|
|---|---|---|---|
|
Overall Complete and Partial Response Rates by FDG Uptake on PET Scan
Overall complete response
|
7 participants
|
—
|
—
|
|
Overall Complete and Partial Response Rates by FDG Uptake on PET Scan
Overall partial response
|
19 participants
|
—
|
—
|
Adverse Events
Induction Chemo + RT + Cisplatin or Cetuximab
Serious events: 19 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 participants at risk
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.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
General disorders
Fatigue
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Leukocytes (WBC)
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Lymphopenia
|
13.3%
4/30 • Number of events 4 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Neutrophils (ANC)
|
16.7%
5/30 • Number of events 5 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Calcium, low
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Potassium, low
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Sodium, low
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Phosphorus, low
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Renal and urinary disorders
Renal failure
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: atrial fibrillation
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Cardiac disorders
Cardiac ischemia
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Skin and subcutaneous tissue disorders
Rash: acneiform
|
13.3%
4/30 • Number of events 4 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Mucositis
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Platelets
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Infections and infestations
Infection with normal ANC-rectal abscess
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Infections and infestations
Infection with grade 4 neutrophils:lung-pneumonia
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Albumin, low
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Glucose, high
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Nervous system disorders
Cerebrovascular ischemia
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Cardiac disorders
Pain:chest
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Vascular disorders
Thrombosis/thrombus/embolism-vascular access device
|
13.3%
4/30 • Number of events 4 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Hemoglobin
|
3.3%
1/30 • Number of events 1 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
Other adverse events
| Measure |
Induction Chemo + RT + Cisplatin or Cetuximab
n=30 participants at risk
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.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
INR
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
PTT
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
General disorders
Fatigue
|
63.3%
19/30 • Number of events 19 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Weight loss
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.7%
11/30 • Number of events 11 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Skin and subcutaneous tissue disorders
Rash:acneiform
|
66.7%
20/30 • Number of events 20 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Skin and subcutaneous tissue disorders
Rash:penile (unconfirmed HSV)
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Constipation
|
23.3%
7/30 • Number of events 7 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Dental:teeth
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Diarrhea
|
43.3%
13/30 • Number of events 13 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Heartburn
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Mucositis
|
20.0%
6/30 • Number of events 6 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Nausea
|
63.3%
19/30 • Number of events 19 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
5/30 • Number of events 5 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Hemoglobin
|
86.7%
26/30 • Number of events 26 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Leukocytes (WBC)
|
70.0%
21/30 • Number of events 21 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Lymphopenia
|
53.3%
16/30 • Number of events 16 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Neutrophils (ANC)
|
50.0%
15/30 • Number of events 15 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Platelets
|
26.7%
8/30 • Number of events 8 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Blood and lymphatic system disorders
Hemorrhage:nose
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Alkaline phosphatase
|
20.0%
6/30 • Number of events 6 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
SGOT (AST)
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
SGPT (ALT)
|
33.3%
10/30 • Number of events 10 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
General disorders
Edema:limb
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Albumin, low
|
20.0%
6/30 • Number of events 6 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Calcium, low
|
36.7%
11/30 • Number of events 11 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Metabolism and nutrition disorders
Glucose, high
|
16.7%
5/30 • Number of events 5 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Magnesium, low
|
30.0%
9/30 • Number of events 9 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Potassium, low
|
16.7%
5/30 • Number of events 5 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Potassium, high
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Sodium, low
|
20.0%
6/30 • Number of events 6 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Nervous system disorders
Neuropathy:sensory (peripheral)
|
20.0%
6/30 • Number of events 6 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain:tumor pain
|
10.0%
3/30 • Number of events 3 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups)
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Investigations
Creatinine
|
23.3%
7/30 • Number of events 7 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
|
Renal and urinary disorders
GFR
|
6.7%
2/30 • Number of events 2 • From time of consent through completion of induction chemotherapy.
Serious adverse events are events grade 3 or higher. Lab results, treatment records, and dictations reviewed weekly.
|
Additional Information
Dr. Douglas R. Adkins
Washington University School of Medicine
Phone: 314-362-5654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place