Trial Outcomes & Findings for Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer (NCT NCT00281840)
NCT ID: NCT00281840
Last Updated: 2015-06-09
Results Overview
The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
5 yrs after treatment
Results posted on
2015-06-09
Participant Flow
Patients recruited from University Hospitals (Cleveland OH) and University of Pittsburgh (Pittsburgh PA) from September 2005 through September 2008.
Participant milestones
| Measure |
Bevacizumab With Docetaxel and Radiation Therapy
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Bevacizumab With Docetaxel and Radiation Therapy
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Disease Progression
|
2
|
|
Overall Study
exceed maximum delay in treatment
|
1
|
|
Overall Study
Complicating Disease
|
1
|
Baseline Characteristics
Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab With Docetaxel and Radiation Therapy
n=30 Participants
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
|
|---|---|
|
Age, Customized
40-49 years
|
4 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
16 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
9 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yrs after treatmentPopulation: Patients who received at least one treatment on study
The time to disease progression is calculated from the date of treatment. Data for patients who remain disease progression free are censored as of date when the last follow-up information is obtained.
Outcome measures
| Measure |
Bevacizumab With Docetaxel and Radiation Therapy
n=30 Participants
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
|
|---|---|
|
Time to Progression
|
44.2 Months
Interval 33.79 to 54.61
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Patients with evaluable tumors at the end of the study
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A response will be determined by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Outcome measures
| Measure |
Bevacizumab With Docetaxel and Radiation Therapy
n=26 Participants
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
|
|---|---|
|
Response Rate
Complete Response
|
16 participants
|
|
Response Rate
Partial Response
|
6 participants
|
|
Response Rate
Progressive Disease
|
1 participants
|
|
Response Rate
Stable Disease
|
3 participants
|
Adverse Events
Bevacizumab With Docetaxel and Radiation Therapy
Serious events: 12 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab With Docetaxel and Radiation Therapy
n=30 participants at risk
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
|
|---|---|
|
Vascular disorders
Hypotension
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism
|
3.3%
1/30 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Wound-Infection
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
2/30 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
10.0%
3/30 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
10.0%
3/30 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Creatinine
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Incontinence
|
3.3%
1/30 • Number of events 1
|
Other adverse events
| Measure |
Bevacizumab With Docetaxel and Radiation Therapy
n=30 participants at risk
Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
20/30 • Number of events 39
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
66.7%
20/30 • Number of events 46
|
|
Gastrointestinal disorders
Mouth dryness
|
63.3%
19/30 • Number of events 28
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
63.3%
19/30 • Number of events 41
|
|
Gastrointestinal disorders
Nausea
|
60.0%
18/30 • Number of events 33
|
|
Gastrointestinal disorders
Anorexia
|
50.0%
15/30 • Number of events 31
|
|
Gastrointestinal disorders
Mucositis due to radiation
|
50.0%
15/30 • Number of events 31
|
|
Gastrointestinal disorders
Vomiting
|
46.7%
14/30 • Number of events 22
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
40.0%
12/30 • Number of events 19
|
|
Gastrointestinal disorders
Gastrointestinal (congestion)
|
30.0%
9/30 • Number of events 12
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
30.0%
9/30 • Number of events 18
|
|
Gastrointestinal disorders
Salivary gland changes
|
26.7%
8/30 • Number of events 13
|
|
Gastrointestinal disorders
Dehydration
|
20.0%
6/30 • Number of events 13
|
|
Gastrointestinal disorders
Dysphagia-pharyngeal related to radiation
|
16.7%
5/30 • Number of events 11
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
96.7%
29/30 • Number of events 54
|
|
General disorders
Weight loss
|
96.7%
29/30 • Number of events 61
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
30.0%
9/30 • Number of events 10
|
|
General disorders
Rigors, chills
|
20.0%
6/30 • Number of events 6
|
|
General disorders
Sweating (diaphoresis)
|
13.3%
4/30 • Number of events 4
|
|
General disorders
Constitutional Symptoms
|
6.7%
2/30 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
90.0%
27/30 • Number of events 58
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
86.7%
26/30 • Number of events 96
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
56.7%
17/30 • Number of events 45
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
26.7%
8/30 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.7%
8/30 • Number of events 27
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
23.3%
7/30 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
5/30 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
3/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.7%
2/30 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.7%
2/30 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
2/30 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemoglobin
|
86.7%
26/30 • Number of events 55
|
|
Blood and lymphatic system disorders
Lymphopenia
|
86.7%
26/30 • Number of events 158
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
23.3%
7/30 • Number of events 13
|
|
Blood and lymphatic system disorders
Platelets
|
10.0%
3/30 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
76.7%
23/30 • Number of events 40
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
53.3%
16/30 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
6/30 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin (erythema)
|
13.3%
4/30 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Flushing
|
13.3%
4/30 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
3/30 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
6.7%
2/30 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
6.7%
2/30 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
73.3%
22/30 • Number of events 55
|
|
Investigations
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
50.0%
15/30 • Number of events 26
|
|
Investigations
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
43.3%
13/30 • Number of events 25
|
|
Investigations
Alkaline phosphatase
|
23.3%
7/30 • Number of events 11
|
|
Investigations
Bilirubin
|
13.3%
4/30 • Number of events 8
|
|
General disorders
Pain
|
86.7%
26/30 • Number of events 71
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
10.0%
3/30 • Number of events 4
|
|
Cardiac disorders
Chest pain (non-cardiac and non-pleuritic)
|
10.0%
3/30 • Number of events 3
|
|
Ear and labyrinth disorders
Earache (otalgia)
|
10.0%
3/30 • Number of events 4
|
|
Injury, poisoning and procedural complications
Pain due to radiation
|
10.0%
3/30 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
6.7%
2/30 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
6.7%
2/30 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
56.7%
17/30 • Number of events 27
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
33.3%
10/30 • Number of events 12
|
|
Nervous system disorders
Neuropathy-sensory
|
33.3%
10/30 • Number of events 14
|
|
Psychiatric disorders
Mood alteration-depression
|
30.0%
9/30 • Number of events 10
|
|
Nervous system disorders
Dizziness/lightheadedness
|
20.0%
6/30 • Number of events 6
|
|
Psychiatric disorders
Confusion
|
13.3%
4/30 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.7%
11/30 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
36.7%
11/30 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
23.3%
7/30 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
23.3%
7/30 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
13.3%
4/30 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
10.0%
3/30 • Number of events 3
|
|
Infections and infestations
Infection without neutropenia
|
40.0%
12/30 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
26.7%
8/30 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
10.0%
3/30 • Number of events 5
|
|
Investigations
Creatinine
|
13.3%
4/30 • Number of events 11
|
|
Renal and urinary disorders
Proteinuria
|
13.3%
4/30 • Number of events 7
|
|
Renal and urinary disorders
Incontinence
|
6.7%
2/30 • Number of events 3
|
|
Vascular disorders
Edema
|
13.3%
4/30 • Number of events 4
|
|
Vascular disorders
Hypotension
|
13.3%
4/30 • Number of events 4
|
|
Cardiac disorders
Sinus tachycardia
|
23.3%
7/30 • Number of events 7
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
2/30 • Number of events 2
|
|
Vascular disorders
Hemorrhage (bloody nose)
|
6.7%
2/30 • Number of events 2
|
|
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
|
6.7%
2/30 • Number of events 3
|
|
Vascular disorders
Hot flashes/flushes
|
10.0%
3/30 • Number of events 3
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
3/30 • Number of events 3
|
|
Ear and labyrinth disorders
Auditory/Hearing (hard of hearing)
|
13.3%
4/30 • Number of events 4
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.7%
2/30 • Number of events 3
|
|
Investigations
Partial thromboplastin time (PTT)
|
6.7%
2/30 • Number of events 2
|
|
Investigations
Prothrombin time (PT)
|
6.7%
2/30 • Number of events 2
|
|
Eye disorders
Vision-blurred vision
|
6.7%
2/30 • Number of events 2
|
Additional Information
Panayiotis Savvides, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-844-5946
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place