Trial Outcomes & Findings for Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer (NCT NCT00140556)
NCT ID: NCT00140556
Last Updated: 2013-01-18
Results Overview
Complete response (resolution) of tumor on clinical exam.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Within 30 days of completing RT
Results posted on
2013-01-18
Participant Flow
Participants were recruited from the multidisciplinary ENT or Radiation Oncology Clinics between September 2005 and February 2009.
Participant milestones
| Measure |
Entire Study Population
|
|---|---|
|
Pre Radiation Period: Avastin / Tarceva
STARTED
|
28
|
|
Pre Radiation Period: Avastin / Tarceva
COMPLETED
|
28
|
|
Pre Radiation Period: Avastin / Tarceva
NOT COMPLETED
|
0
|
|
Chemoradiotherapy Period
STARTED
|
28
|
|
Chemoradiotherapy Period
COMPLETED
|
28
|
|
Chemoradiotherapy Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=28 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
57 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Feeding Tube
Feeding Tube Present Baseline
|
4 Participants
n=5 Participants
|
|
Feeding Tube
No Feeding Tube at Baseline
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of completing RTPopulation: 2 participants had occult primaries, thus were not included in clinical complete response
Complete response (resolution) of tumor on clinical exam.
Outcome measures
| Measure |
Entire Study Population
n=26 Participants
|
|---|---|
|
Tumor Resolution
|
25 Participants
|
SECONDARY outcome
Timeframe: 1 yr following chemoradiationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yrsOutcome measures
Outcome data not reported
Adverse Events
Entire Study Population
Serious events: 15 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Study Population
n=28 participants at risk
|
|---|---|
|
Cardiac disorders
Bradycardia
|
3.6%
1/28 • Number of events 1 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
7/28 • Number of events 7 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Infections and infestations
Febrile Neutropenia
|
10.7%
3/28 • Number of events 4 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
General disorders
Fever
|
10.7%
3/28 • Number of events 3 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Mucositis
|
7.1%
2/28 • Number of events 2 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
4/28 • Number of events 5 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
2/28 • Number of events 2 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Nervous system disorders
Seizure
|
3.6%
1/28 • Number of events 1 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.6%
1/28 • Number of events 1 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Vascular disorders
Vasculitis
|
3.6%
1/28 • Number of events 1 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
Other adverse events
| Measure |
Entire Study Population
n=28 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Anorexia
|
7.1%
2/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Dehydration
|
64.3%
18/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Dental, periodontal disease
|
10.7%
3/28 • Number of events 3 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Diarrhea
|
17.9%
5/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Dry Mouth
|
21.4%
6/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Dysphagia
|
46.4%
13/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
General disorders
Fatigue
|
32.1%
9/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
7.1%
2/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Cardiac disorders
Hypertension
|
14.3%
4/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Infections and infestations
Mucosal Infection
|
60.7%
17/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Mucositis, Oropharyngeal
|
92.9%
26/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
21/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
17.9%
5/28 • Number of events 5 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Skin and subcutaneous tissue disorders
Radiation Dermatitis
|
35.7%
10/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
53.6%
15/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
10.7%
3/28 • Number of events 3 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
8/28 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
|
General disorders
Weight Loss
|
53.6%
15/28 • Number of events 15 • Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.
Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.
|
Additional Information
David Brizel, MD
Duke University Medical Center, Dept Radiation Oncology
Phone: 919 668-5637
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60