Trial Outcomes & Findings for Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer (NCT NCT01790516)
NCT ID: NCT01790516
Last Updated: 2014-10-02
Results Overview
Feasibility is defined as follows: \- Patients' genetic test results are returned to the treating physician within 3 days
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
20 months
Results posted on
2014-10-02
Participant Flow
Participant milestones
| Measure |
Cisplatin
Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
|
Cetuximab
Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cisplatin
Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
|
Cetuximab
Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin
n=1 Participants
Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
|
Cetuximab
n=1 Participants
Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
|
Total
n=2 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 monthsFeasibility is defined as follows: \- Patients' genetic test results are returned to the treating physician within 3 days
Outcome measures
| Measure |
Cisplatin
n=1 Participants
Intensity modulated radiation with concurrent cisplatin
platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
|
Cetuximab
n=1 Participants
Intensity modulated radiation therapy with concurrent cetuximab
cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
|
|---|---|---|
|
Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician
|
3 days
Interval 3.0 to 3.0
|
3 days
Interval 3.0 to 3.0
|
Adverse Events
Cisplatin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cetuximab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place