Trial Outcomes & Findings for Treatment of Head & Neck Cancer With Chemotherapy and Radiation (NCT NCT00392704)
NCT ID: NCT00392704
Last Updated: 2013-02-22
Results Overview
The percentage of patients estimated to be alive 2 years after beginning protocol treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
24 months
Results posted on
2013-02-22
Participant Flow
Participant milestones
| Measure |
Intervention
All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation.
|
|---|---|
|
Neoadjuvant Chemotherapy
STARTED
|
60
|
|
Neoadjuvant Chemotherapy
COMPLETED
|
54
|
|
Neoadjuvant Chemotherapy
NOT COMPLETED
|
6
|
|
Combined Modality Therapy
STARTED
|
54
|
|
Combined Modality Therapy
COMPLETED
|
49
|
|
Combined Modality Therapy
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Head & Neck Cancer With Chemotherapy and Radiation
Baseline characteristics by cohort
| Measure |
Intervention
n=60 Participants
All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation.
|
|---|---|
|
Age Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All participants in this study were assessed and included in the progression free survival analysis
The percentage of patients estimated to be alive 2 years after beginning protocol treatment
Outcome measures
| Measure |
Intervention
n=60 Participants
All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation.
|
|---|---|
|
Two-Year Progression Free Survival (PFS) Probability, the Percentage of Patients Estimated to be Alive Without Worsening of Their Disease Two Years After Beginning Protocol Treatment
|
83 percentage of participants
|
SECONDARY outcome
Timeframe: 24 MonthsThe Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
Outcome measures
| Measure |
Intervention
n=60 Participants
All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation.
|
|---|---|
|
Overall Survival (OS)Probability, the Percentage of Patients Estimated to be Alive Two Years After Beginning Protocol Treatment
|
90 percentage of patients
|
Adverse Events
Intervention
Serious events: 24 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=60 participants at risk
All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation.
|
|---|---|
|
Infections and infestations
Febrile Neutropenia
|
5.0%
3/60 • Number of events 3
|
|
Infections and infestations
Infection - Sepsis
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Infection with Unknown ANC
|
3.3%
2/60 • Number of events 2
|
|
Surgical and medical procedures
Hemorrhage with Surgery
|
1.7%
1/60 • Number of events 2
|
|
Infections and infestations
Infection - Pneumonia
|
3.3%
2/60 • Number of events 2
|
|
Vascular disorders
CNS Ischemia
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/60 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Fever
|
3.3%
2/60 • Number of events 2
|
|
General disorders
Weakness
|
3.3%
2/60 • Number of events 3
|
|
Gastrointestinal disorders
Diverticulitis
|
1.7%
1/60 • Number of events 2
|
|
Gastrointestinal disorders
Pneumatosis Intestinalis
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
6.7%
4/60 • Number of events 5
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
3/60 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
3/60 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
3.3%
2/60 • Number of events 2
|
|
Gastrointestinal disorders
Fistula, GI
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Pain
|
1.7%
1/60 • Number of events 1
|
Other adverse events
| Measure |
Intervention
n=60 participants at risk
All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.
One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation.
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
10.0%
6/60 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.3%
32/60 • Number of events 67
|
|
Metabolism and nutrition disorders
ALT
|
8.3%
5/60 • Number of events 7
|
|
Gastrointestinal disorders
Anorexia
|
55.0%
33/60 • Number of events 52
|
|
Metabolism and nutrition disorders
AST
|
13.3%
8/60 • Number of events 8
|
|
Metabolism and nutrition disorders
Bilirubin
|
10.0%
6/60 • Number of events 6
|
|
General disorders
Rigor/Chills
|
6.7%
4/60 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
41.7%
25/60 • Number of events 36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
10/60 • Number of events 11
|
|
Metabolism and nutrition disorders
Creatinine
|
6.7%
4/60 • Number of events 4
|
|
Gastrointestinal disorders
Dehydration
|
63.3%
38/60 • Number of events 55
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
10.0%
6/60 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhea
|
63.3%
38/60 • Number of events 69
|
|
Nervous system disorders
Dizziness
|
15.0%
9/60 • Number of events 15
|
|
Gastrointestinal disorders
Dry Mouth
|
21.7%
13/60 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
15.0%
9/60 • Number of events 12
|
|
Gastrointestinal disorders
Dysphagia
|
41.7%
25/60 • Number of events 30
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
3/60 • Number of events 4
|
|
Blood and lymphatic system disorders
Edema - Neck
|
5.0%
3/60 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
12/60 • Number of events 18
|
|
Gastrointestinal disorders
Esophagitis
|
25.0%
15/60 • Number of events 17
|
|
General disorders
Fatigue
|
73.3%
44/60 • Number of events 105
|
|
General disorders
Fever
|
28.3%
17/60 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Syndrome
|
21.7%
13/60 • Number of events 20
|
|
Blood and lymphatic system disorders
Hemoglobin
|
65.0%
39/60 • Number of events 72
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
18.3%
11/60 • Number of events 14
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
4/60 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.7%
13/60 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.7%
4/60 • Number of events 4
|
|
Cardiac disorders
Hypertension
|
8.3%
5/60 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.3%
8/60 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
3/60 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
3/60 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
5/60 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
6/60 • Number of events 6
|
|
Cardiac disorders
Hypotension
|
11.7%
7/60 • Number of events 8
|
|
Infections and infestations
Infection - NOS
|
10.0%
6/60 • Number of events 6
|
|
Infections and infestations
Infection - PEG Site
|
13.3%
8/60 • Number of events 9
|
|
Infections and infestations
Infection - Throat
|
10.0%
6/60 • Number of events 10
|
|
General disorders
Insomnia
|
23.3%
14/60 • Number of events 21
|
|
Blood and lymphatic system disorders
Leukocytes
|
66.7%
40/60 • Number of events 81
|
|
Metabolism and nutrition disorders
Malnutrition
|
5.0%
3/60 • Number of events 4
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
13.3%
8/60 • Number of events 16
|
|
Psychiatric disorders
Mood Alteration - Depression
|
11.7%
7/60 • Number of events 11
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
95.0%
57/60 • Number of events 118
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
10.0%
6/60 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
61.7%
37/60 • Number of events 65
|
|
Blood and lymphatic system disorders
Neutrophils
|
71.7%
43/60 • Number of events 60
|
|
General disorders
Pain - NOS
|
85.0%
51/60 • Number of events 127
|
|
General disorders
Pain - Joint
|
5.0%
3/60 • Number of events 4
|
|
Blood and lymphatic system disorders
Platelets
|
45.0%
27/60 • Number of events 46
|
|
Metabolism and nutrition disorders
Proteinuria
|
13.3%
8/60 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.3%
8/60 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Burn
|
18.3%
11/60 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.7%
4/60 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
73.3%
44/60 • Number of events 89
|
|
Gastrointestinal disorders
Reflux
|
6.7%
4/60 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
8.3%
5/60 • Number of events 6
|
|
Nervous system disorders
Neuropathy - Sensory
|
43.3%
26/60 • Number of events 48
|
|
Cardiac disorders
Superventricular Arrhythmia
|
6.7%
4/60 • Number of events 5
|
|
General disorders
Sweating
|
5.0%
3/60 • Number of events 3
|
|
Nervous system disorders
Syncope
|
5.0%
3/60 • Number of events 3
|
|
Gastrointestinal disorders
Taste Alteration
|
26.7%
16/60 • Number of events 22
|
|
Gastrointestinal disorders
Vomiting
|
41.7%
25/60 • Number of events 33
|
|
Metabolism and nutrition disorders
Weight Loss
|
41.7%
25/60 • Number of events 39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER