Trial Outcomes & Findings for Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer (NCT NCT00713219)
NCT ID: NCT00713219
Last Updated: 2015-04-23
Results Overview
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 measureable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
conclusion of the study
Results posted on
2015-04-23
Participant Flow
Participant milestones
| Measure |
Docetaxel + Cetuximab + Concurrent Re-Irradiation
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Docetaxel + Cetuximab + Concurrent Re-Irradiation
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients With Locoregionally Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel + Cetuximab + Concurrent Re-Irradiation
n=14 Participants
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: conclusion of the studyProgression 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 measureable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Docetaxel + Cetuximab + Concurrent Re-Irradiation
n=12 Participants
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
|
|---|---|
|
Overall Progression-Free Survival (PFS).
|
370 Days
Interval 91.0 to 1186.0
|
Adverse Events
Docetaxel + Cetuximab + Concurrent Re-Irradiation
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel + Cetuximab + Concurrent Re-Irradiation
n=14 participants at risk
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
|
|---|---|
|
General disorders
Dehydration
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Syncope (fainting)
|
14.3%
2/14 • Number of events 2
|
|
Ear and labyrinth disorders
Ocular/Visual - Other (specify)
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Dizziness
|
7.1%
1/14 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Allergic reaction (including drug fever)
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection unknown ANC-Pneumonia(lung)
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Hemorrhage, Oral cavity
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection, other
|
14.3%
2/14 • Number of events 2
|
Other adverse events
| Measure |
Docetaxel + Cetuximab + Concurrent Re-Irradiation
n=14 participants at risk
Docetaxel + Cetuximab + Concurrent Re-Irradiation (Intensity - Modulated Radiation Therapy, IMRT) for Patients with Locoregionally Recurrent Head and Neck Cancer
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Dehydration
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Dysphagia (Difficulty swallowing)
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Edema: limb
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
21.4%
3/14 • Number of events 6
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
21.4%
3/14 • Number of events 5
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
7.1%
1/14 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
7.1%
1/14 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
14.3%
2/14 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
71.4%
10/14 • Number of events 13
|
|
General disorders
Mucositis (Clinical exam)- Oral cavity
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Mucositis (symptoms)- Oral cavity
|
14.3%
2/14 • Number of events 2
|
|
Eye disorders
Ocular/Visual
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain
|
21.4%
3/14 • Number of events 3
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
14.3%
2/14 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with Chemoradiation
|
21.4%
3/14 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with Radiation
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
7.1%
1/14 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
14.3%
2/14 • Number of events 3
|
Additional Information
Dr. Matthew Fury
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place