Trial Outcomes & Findings for Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer (NCT NCT00541099)
NCT ID: NCT00541099
Last Updated: 2019-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
6 months when treated with combination of Avastin and weekly docetaxel
Results posted on
2019-03-27
Participant Flow
Participant milestones
| Measure |
Avastin & Docetaxel
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Avastin & Docetaxel
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Overall Study
Ineligible
|
3
|
Baseline Characteristics
Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Avastin & Docetaxel
n=8 Participants
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Age, Continuous
|
79.7 years
STANDARD_DEVIATION 4.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months when treated with combination of Avastin and weekly docetaxelOutcome measures
| Measure |
Avastin & Docetaxel
n=8 Participants
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Survival
|
75 percentage of participants surviving
Interval 40.0 to 95.0
|
SECONDARY outcome
Timeframe: 6 months when treated with combination of Avastin and weekly docetaxelPopulation: No patient showed a response, therefore all patients had 0 for PFS
Progression-free survival in months via the Kaplan-Meier method
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeks after removal from study or until deathOverall survival using Kaplan-Meier method.
Outcome measures
| Measure |
Avastin & Docetaxel
n=8 Participants
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Overall Survival
|
35.7 months
Interval 1.7 to 41.3
|
SECONDARY outcome
Timeframe: Every 8 weeksOutcome measures
| Measure |
Avastin & Docetaxel
n=8 Participants
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: 1st and 2nd week of each 21 day cycle, up to six cycles.Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Avastin & Docetaxel
n=8 Participants
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Serious (grade 3 or 4)
|
21 Adverse event
|
|
Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
other (grade 0, 1, or 2)
|
123 Adverse event
|
Adverse Events
Avastin & Docetaxel
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Avastin & Docetaxel
n=8 participants at risk
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Blood and lymphatic system disorders
Decreased ANC
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Decreased WBC
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
25.0%
2/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
3/8 • Number of events 8
|
|
Cardiac disorders
Hypertension
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
2/8 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Proteinuria
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Syncope
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Urosepsis
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Perineal abscess
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Avastin & Docetaxel
n=8 participants at risk
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
bevacizumab: Avastin 10.0 mg/kg on days 1 and 15
docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
|
|---|---|
|
Skin and subcutaneous tissue disorders
Brittle Nails
|
12.5%
1/8 • Number of events 2
|
|
Psychiatric disorders
Insomina
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
UTI
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
Acute Colitis
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Alkaline Phosphatase
|
12.5%
1/8 • Number of events 1
|
|
Immune system disorders
Allergic Reaction
|
12.5%
1/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
4/8 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
4/8 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bilateral Leg Pain
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Chest Wall Rash
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Number of events 3
|
|
Investigations
Decreased HgB
|
25.0%
2/8 • Number of events 7
|
|
Investigations
Decreased WBC
|
37.5%
3/8 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
6/8 • Number of events 19
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
12.5%
1/8 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
25.0%
2/8 • Number of events 2
|
|
Eye disorders
Eye Tearing
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
75.0%
6/8 • Number of events 16
|
|
Vascular disorders
Flushing
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
12.5%
1/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
1/8 • Number of events 5
|
|
Investigations
Hemoglobin
|
12.5%
1/8 • Number of events 5
|
|
Vascular disorders
HTN
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
2/8 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
12.5%
1/8 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
62.5%
5/8 • Number of events 15
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 2
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Increased Creatinine
|
12.5%
1/8 • Number of events 2
|
|
Eye disorders
Lacrimation
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Lymphopenia
|
12.5%
1/8 • Number of events 6
|
|
Gastrointestinal disorders
Metallic taste
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleed
|
37.5%
3/8 • Number of events 3
|
|
Gastrointestinal disorders
Oral Thrush
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Pain: Chest/Torax NOS
|
12.5%
1/8 • Number of events 2
|
|
Cardiac disorders
Pericardial Effusion
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
pain: Trauma site
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
37.5%
3/8 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
2/8 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
1/8 • Number of events 2
|
|
General disorders
R. Arm Extravasation
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
R. Elbow-Soft Tissue Trauma
|
12.5%
1/8 • Number of events 3
|
|
Nervous system disorders
Sensory Neuropathy
|
25.0%
2/8 • Number of events 2
|
|
Reproductive system and breast disorders
Sinus Congest
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Drainage
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin peeling-hands
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Taste Alteration
|
50.0%
4/8 • Number of events 6
|
|
Eye disorders
Tearing in eyes
|
12.5%
1/8 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
upper resp infection
|
12.5%
1/8 • Number of events 1
|
|
Renal and urinary disorders
Urinary Frequency
|
12.5%
1/8 • Number of events 2
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Vasovagal episode
|
12.5%
1/8 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 3
|
|
Eye disorders
Watery Eye
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Weight Loss
|
25.0%
2/8 • Number of events 5
|
|
Gastrointestinal disorders
Edema: limbs
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Edema: trunk/genital
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Arm Laceration
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Decubitus
|
12.5%
1/8 • Number of events 2
|
|
Vascular disorders
Hypertension
|
37.5%
3/8 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukpenia
|
12.5%
1/8 • Number of events 2
|
Additional Information
Shirish Gadgeel, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: (313) 576-8753
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place