Trial Outcomes & Findings for Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer (NCT NCT00891904)
NCT ID: NCT00891904
Last Updated: 2016-04-14
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
Daily while on Treatment
Results posted on
2016-04-14
Participant Flow
Participant milestones
| Measure |
Biological/Vaccine: Cetuximab
All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Biological/Vaccine: Cetuximab
All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Radiation Therapy and Cetuximab in Treating Patients With Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Biological/Vaccine: Cetuximab
n=2 Participants
All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).
|
|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 2.8 • n=99 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Daily while on TreatmentPopulation: Trial terminated early. Too few patients to analyze.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Trial terminated early. Too few patients to analyze.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.Population: Trial terminated early. Too few patients to analyze.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafterPopulation: Trial terminated early. Too few patients to analyze.
Outcome measures
Outcome data not reported
Adverse Events
Biological/Vaccine: Cetuximab
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biological/Vaccine: Cetuximab
n=2 participants at risk
All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).
|
|---|---|
|
Infections and infestations
Pneumonia
|
50.0%
1/2 • Number of events 2
|
|
Infections and infestations
Postoperative wound infection
|
50.0%
1/2 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
50.0%
1/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
50.0%
1/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • Number of events 4
|
Other adverse events
| Measure |
Biological/Vaccine: Cetuximab
n=2 participants at risk
All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.
250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2).
|
|---|---|
|
Blood and lymphatic system disorders
White blood cell disorder
|
50.0%
1/2 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 4
|
|
Investigations
Haemoglobin decreased
|
50.0%
1/2 • Number of events 4
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 8
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
50.0%
1/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
50.0%
1/2 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
50.0%
1/2 • Number of events 4
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place