Trial Outcomes & Findings for Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer (NCT NCT00581971)
NCT ID: NCT00581971
Last Updated: 2013-04-25
Results Overview
Particpants experiencing Acute Toxicities \> Grade 3
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
2 years from radiation therapy
Results posted on
2013-04-25
Participant Flow
Participant milestones
| Measure |
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
n=30 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age Continuous
|
53.83 years
STANDARD_DEVIATION 8.06 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 years from radiation therapyParticpants experiencing Acute Toxicities \> Grade 3
Outcome measures
| Measure |
Acute Toxicity
n=30 Participants
Participants that experienced Grade 3 or higher toxicity factors.
|
|---|---|
|
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Hematologic
|
12 participants
|
|
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Dermatitis
|
7 participants
|
|
Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.
Mucositis/Dysphagia
|
16 participants
|
PRIMARY outcome
Timeframe: 2 years from end of treatment (Radiation therapy)Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.
Outcome measures
| Measure |
Acute Toxicity
n=14 Participants
Participants that experienced Grade 3 or higher toxicity factors.
|
|---|---|
|
Response as Evaluated by Recurrence of Diseases
Local Control Only
|
6 Participants
|
|
Response as Evaluated by Recurrence of Diseases
Local Control and Distant Metastasis
|
2 Participants
|
|
Response as Evaluated by Recurrence of Diseases
Distant Metastatsis Only
|
1 Participants
|
|
Response as Evaluated by Recurrence of Diseases
Secondary Primary - Site Unknown
|
2 Participants
|
|
Response as Evaluated by Recurrence of Diseases
Surgical Salvage
|
3 Participants
|
Adverse Events
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
Serious events: 12 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
n=30 participants at risk
|
|---|---|
|
Vascular disorders
Stroke
|
3.3%
1/30 • Number of events 1
|
|
Immune system disorders
Febrile Neutropenia
|
6.7%
2/30 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
3.3%
1/30 • Number of events 1
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
3/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Radiation Dermatitis
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Fever (in absence of Neutropenia)
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy
n=30 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Mucositis
|
26.7%
8/30 • Number of events 9
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
10/30 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Radiation Dermatitis
|
16.7%
5/30 • Number of events 7
|
|
Gastrointestinal disorders
Dysphagia
|
70.0%
21/30 • Number of events 24
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
3/30 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
2/30 • Number of events 2
|
Additional Information
Dr. Sharon Spencer Professor of Radiation Oncology
UAB Hospital
Phone: 205-934-2762
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place