Trial Outcomes & Findings for Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer (NCT NCT00468169)
NCT ID: NCT00468169
Last Updated: 2019-10-09
Results Overview
Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
1 years
Results posted on
2019-10-09
Participant Flow
Participant milestones
| Measure |
A: Cetuximab+FHX
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
|
Overall Study
COMPLETED
|
56
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
A: Cetuximab+FHX
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
A: Cetuximab+FHX
n=57 Participants
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 Participants
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 years
n=99 Participants
|
55.6 years
n=107 Participants
|
55.8 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearsKaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
A: Cetuximab+FHX
n=57 Participants
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 Participants
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Progression Free Survival (PFS)
|
87.7 Probability (%)
Interval 76.0 to 94.0
|
92.5 Probability (%)
Interval 81.1 to 97.1
|
PRIMARY outcome
Timeframe: 2 yearsTime from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
A: Cetuximab+FHX
n=57 Participants
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 Participants
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Progression Free Survival (PFS)
|
82.5 Probability (%)
Interval 71.9 to 91.5
|
84.9 Probability (%)
Interval 72.1 to 92.2
|
SECONDARY outcome
Timeframe: 2 yearsTime from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.
Outcome measures
| Measure |
A: Cetuximab+FHX
n=57 Participants
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 Participants
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Overall Survival (OS)
|
91.2 Probability (%)
Interval 80.2 to 96.3
|
94.3 Probability (%)
Interval 83.5 to 98.1
|
SECONDARY outcome
Timeframe: Post-Induction (8 weeks)Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
A: Cetuximab+FHX
n=57 Participants
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 Participants
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Objective Response Rate to Induction
Complete Response (CR)
|
7 Participants
|
4 Participants
|
|
Objective Response Rate to Induction
Partial Response (PR)
|
47 Participants
|
41 Participants
|
|
Objective Response Rate to Induction
Stable Disease (SD)
|
3 Participants
|
7 Participants
|
|
Objective Response Rate to Induction
Progressive Disease (PD)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeksResponse to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
Outcome measures
| Measure |
A: Cetuximab+FHX
n=57 Participants
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 Participants
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Objective Response Rate to CRT
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 10 weeksResponse to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (\>1.5 cm) or focally abnormal lymph node.
Outcome measures
| Measure |
A: Cetuximab+FHX
n=57 Participants
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 Participants
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Residual Lymph Node Disease
|
2 Participants
|
6 Participants
|
Adverse Events
A: Cetuximab+FHX
Serious events: 7 serious events
Other events: 57 other events
Deaths: 14 deaths
B: Cetuximab + PX
Serious events: 14 serious events
Other events: 53 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
A: Cetuximab+FHX
n=57 participants at risk
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 participants at risk
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/57 • 24 months
|
1.9%
1/53 • 24 months
|
|
General disorders
Fever
|
3.5%
2/57 • 24 months
|
9.4%
5/53 • 24 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.0%
4/57 • 24 months
|
0.00%
0/53 • 24 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/57 • 24 months
|
1.9%
1/53 • 24 months
|
|
General disorders
Pain
|
0.00%
0/57 • 24 months
|
3.8%
2/53 • 24 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/57 • 24 months
|
1.9%
1/53 • 24 months
|
|
Cardiac disorders
Pericarditis
|
1.8%
1/57 • 24 months
|
0.00%
0/53 • 24 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/57 • 24 months
|
1.9%
1/53 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/57 • 24 months
|
3.8%
2/53 • 24 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/57 • 24 months
|
1.9%
1/53 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/57 • 24 months
|
5.7%
3/53 • 24 months
|
|
Metabolism and nutrition disorders
G-tube placement
|
1.8%
1/57 • 24 months
|
5.7%
3/53 • 24 months
|
|
Metabolism and nutrition disorders
Malnourished
|
0.00%
0/57 • 24 months
|
3.8%
2/53 • 24 months
|
|
Nervous system disorders
Presyncopal episode
|
0.00%
0/57 • 24 months
|
1.9%
1/53 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
3.5%
2/57 • 24 months
|
1.9%
1/53 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
2/57 • 24 months
|
1.9%
1/53 • 24 months
|
Other adverse events
| Measure |
A: Cetuximab+FHX
n=57 participants at risk
Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
B: Cetuximab + PX
n=53 participants at risk
Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7)
|
|---|---|---|
|
Investigations
Weight loss
|
89.5%
51/57 • 24 months
|
69.8%
37/53 • 24 months
|
|
Investigations
Neutrophil count decreased
|
84.2%
48/57 • 24 months
|
84.9%
45/53 • 24 months
|
|
Investigations
Hemoglobin increased
|
75.4%
43/57 • 24 months
|
67.9%
36/53 • 24 months
|
|
Investigations
White blood cell decreased
|
80.7%
46/57 • 24 months
|
88.7%
47/53 • 24 months
|
|
Investigations
Platelet count decreased
|
22.8%
13/57 • 24 months
|
24.5%
13/53 • 24 months
|
|
Investigations
Creatinine increased
|
10.5%
6/57 • 24 months
|
7.5%
4/53 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
86.0%
49/57 • 24 months
|
84.9%
45/53 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
47.4%
27/57 • 24 months
|
35.8%
19/53 • 24 months
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
57/57 • 24 months
|
100.0%
53/53 • 24 months
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
98.2%
56/57 • 24 months
|
100.0%
53/53 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
80.7%
46/57 • 24 months
|
75.5%
40/53 • 24 months
|
|
General disorders
Fatigue
|
98.2%
56/57 • 24 months
|
100.0%
53/53 • 24 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
31.6%
18/57 • 24 months
|
37.7%
20/53 • 24 months
|
|
General disorders
Fever
|
40.4%
23/57 • 24 months
|
58.5%
31/53 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
71.9%
41/57 • 24 months
|
73.6%
39/53 • 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
87.7%
50/57 • 24 months
|
92.5%
49/53 • 24 months
|
|
General disorders
Pain
|
100.0%
57/57 • 24 months
|
100.0%
53/53 • 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
43.9%
25/57 • 24 months
|
37.7%
20/53 • 24 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
98.2%
56/57 • 24 months
|
45.3%
24/53 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
98.2%
56/57 • 24 months
|
100.0%
53/53 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
87.7%
50/57 • 24 months
|
92.5%
49/53 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place