Trial Outcomes & Findings for Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (NCT NCT00661427)
NCT ID: NCT00661427
Last Updated: 2018-01-11
Results Overview
Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Approximately every 8 weeks with imaging up to two years
Results posted on
2018-01-11
Participant Flow
Participant milestones
| Measure |
Cetuximab Infusion at 500 mg/m^2
Cetuximab infusion at 500 mg/m\^2 over 2 hours every other week.
|
Cetuximab Infusion at 750 mg/m^2
Cetuximab infusion at 750 mg/m\^2 over 3 hours every other week.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
26
|
|
Overall Study
COMPLETED
|
30
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Cetuximab Infusion at 500 mg/m^2
Cetuximab infusion at 500 mg/m\^2 over 2 hours every other week.
|
Cetuximab Infusion at 750 mg/m^2
Cetuximab infusion at 750 mg/m\^2 over 3 hours every other week.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Patient not treated
|
0
|
2
|
Baseline Characteristics
Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=35 Participants
Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
|
Arm B
n=26 Participants
Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately every 8 weeks with imaging up to two yearsPatients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam
Outcome measures
| Measure |
Arm A
n=30 Participants
Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
|
Arm B
n=19 Participants
Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
|
|---|---|---|
|
Number of Patients With Overall Objective Response
Partial Response (PR)
|
4 participants
|
2 participants
|
|
Number of Patients With Overall Objective Response
Stable Disease (SD)
|
12 participants
|
5 participants
|
|
Number of Patients With Overall Objective Response
Progression of Disease (POD)
|
14 participants
|
12 participants
|
SECONDARY outcome
Timeframe: at least weeklyTerminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity.
Outcome measures
| Measure |
Arm A
n=30 Participants
Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
|
Arm B
n=19 Participants
Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
|
|---|---|---|
|
The Total Number of Participants That Were Effected by Adverse Events.
|
28 Participants
|
18 Participants
|
Adverse Events
Arm A
Serious events: 18 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm B
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=30 participants at risk
Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
|
Arm B
n=19 participants at risk
Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
|
|---|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Allergic reaction (including drug fever)
|
10.0%
3/30 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Confusion
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Death not associated with CTCAE term- Death NOS
|
6.7%
2/30 • Number of events 2
|
0.00%
0/19
|
|
General disorders
Death not associated with CTCAE term-Disease progression NOS
|
13.3%
4/30 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Dehydration
|
6.7%
2/30 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Dysphagia (Difficulty swallowing)
|
3.3%
1/30 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.3%
4/30 • Number of events 5
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.3%
1/30 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
6.7%
2/30 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.7%
2/30 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Ileus, GI (func obstruction of bowel)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Blood and lymphatic system disorders
Inf norm ANC/gr1/2 neut-Pneumonia(lung)
|
13.3%
4/30 • Number of events 4
|
0.00%
0/19
|
|
Infections and infestations
Infection w/ Gr 3/4 neut, Lung (pneumonia)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Nausea
|
6.7%
2/30 • Number of events 2
|
0.00%
0/19
|
|
Endocrine disorders
Neuroendocrine: ADH secretion abnormal
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Pain
|
16.7%
5/30 • Number of events 5
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
3.3%
1/30 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
10.0%
3/30 • Number of events 5
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
3.3%
1/30 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Somnolence/depressd level of conscious
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Vomiting
|
3.3%
1/30 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Calcium, high (hypercalcemia)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - Whole body/general
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Arm A
n=30 participants at risk
Cetuximab infusion at 500 mg/m2 over 2 hours every other week.
|
Arm B
n=19 participants at risk
Cetuximab infusion at 750 mg/m2 over 3 hours every other week.
|
|---|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
6.7%
2/30 • Number of events 2
|
0.00%
0/19
|
|
General disorders
Anorexia
|
10.0%
3/30 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 2
|
0.00%
0/19
|
|
General disorders
Dehydration
|
6.7%
2/30 • Number of events 2
|
0.00%
0/19
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • Number of events 2
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.3%
4/30 • Number of events 4
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.7%
2/30 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.0%
12/30 • Number of events 15
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
13.3%
4/30 • Number of events 4
|
26.3%
5/19 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemoglobin
|
10.0%
3/30 • Number of events 3
|
15.8%
3/19 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
5/30 • Number of events 5
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
0.00%
0/30
|
15.8%
3/19 • Number of events 3
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
10.0%
3/30 • Number of events 3
|
0.00%
0/19
|
|
General disorders
Mucositis (func/sympt)- Oral cavity
|
6.7%
2/30 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Muscle weakness - Whole body/general
|
6.7%
2/30 • Number of events 2
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.0%
3/30 • Number of events 3
|
0.00%
0/19
|
|
General disorders
Pain
|
46.7%
14/30 • Number of events 20
|
31.6%
6/19 • Number of events 6
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
6.7%
2/30 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.7%
2/30 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
36.7%
11/30 • Number of events 15
|
42.1%
8/19 • Number of events 9
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
10.0%
3/30 • Number of events 3
|
0.00%
0/19
|
|
General disorders
Trismus
|
10.0%
3/30 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Weight loss
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Vomiting
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/30
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Taste alteration (dysgeusia)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Syncope (fainting)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, high (hypernatremia)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.00%
0/30
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 2
|
|
Nervous system disorders
Neuropathy: motor
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Nausea
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Infection, other
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut
|
0.00%
0/30
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/30
|
5.3%
1/19 • Number of events 1
|
Additional Information
Dr. David Pfister
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place