Trial Outcomes & Findings for Bevacizumab (Avastin®) + Erlotinib as First-line Therapy for Stage IIIB/IV or Recurrent, Non-squamous Cell Lung Cancer (NCT NCT00585377)
NCT ID: NCT00585377
Last Updated: 2015-09-24
Results Overview
The length of time from the start of treatment for a disease that patients are still alive.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
2 years
Results posted on
2015-09-24
Participant Flow
Participant milestones
| Measure |
Arm 1:Bevacizumab and Erlotinib
Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab (Avastin®) + Erlotinib as First-line Therapy for Stage IIIB/IV or Recurrent, Non-squamous Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=50 Participants
Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
|
|---|---|
|
Age, Continuous
|
65 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: All patients were included in response assessment based on intention to treat including those who received less than 6 weeks of therapy
The length of time from the start of treatment for a disease that patients are still alive.
Outcome measures
| Measure |
Arm 1:Bevacizumab and Erlotinib
n=50 Participants
Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
|
|---|---|
|
Evaluation of Overall Survival
|
50.4 weeks
Interval 43.2 to 57.6
|
SECONDARY outcome
Timeframe: 2 yearsThe length of time during and after bevacizumab-erlotinib that a patient lives with the disease but does not progress according to RECIST 1.0 Criteria. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Arm 1:Bevacizumab and Erlotinib
n=50 Participants
Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
|
|---|---|
|
Evaluation of Progression-free Survival
|
15.5 weeks
Interval 13.3 to 17.7
|
SECONDARY outcome
Timeframe: 2 yearsThe percentage of patients in which response (CR + PR) was observed: Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Arm 1:Bevacizumab and Erlotinib
n=50 Participants
Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
|
|---|---|
|
Evaluation of Response Rate
|
24 percentage of participants
Interval 12.2 to 35.8
|
Adverse Events
Arm 1
Serious events: 16 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=50 participants at risk
Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Confusion
|
2.0%
1/50 • Number of events 1
|
|
Investigations
death
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture Bone-Hip
|
4.0%
2/50 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemmorrhage: Pulmonary
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection: Abdomen
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection: Lung (pneumonia)
|
8.0%
4/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Lipase Elevated
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Pain: Abdominal
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Pain: Chest
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
10.0%
5/50 • Number of events 5
|
|
Nervous system disorders
Reversibly Encephalopathy Syndrome
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
Arm 1
n=50 participants at risk
Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline Phosphatase: Increased
|
20.0%
10/50 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.0%
7/50 • Number of events 8
|
|
Metabolism and nutrition disorders
ALT Increase
|
20.0%
10/50 • Number of events 16
|
|
Gastrointestinal disorders
Anorexia
|
60.0%
30/50 • Number of events 38
|
|
Metabolism and nutrition disorders
AST Increase
|
28.0%
14/50 • Number of events 17
|
|
Nervous system disorders
Ataxia
|
8.0%
4/50 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Bruising
|
6.0%
3/50 • Number of events 3
|
|
Investigations
Chills
|
16.0%
8/50 • Number of events 8
|
|
Nervous system disorders
Confusion
|
12.0%
6/50 • Number of events 6
|
|
Gastrointestinal disorders
Constipation
|
14.0%
7/50 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.0%
11/50 • Number of events 15
|
|
Metabolism and nutrition disorders
Creatinine Increased
|
14.0%
7/50 • Number of events 10
|
|
Gastrointestinal disorders
Dehydration
|
22.0%
11/50 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhea
|
68.0%
34/50 • Number of events 56
|
|
Nervous system disorders
Dizziness
|
12.0%
6/50 • Number of events 7
|
|
Gastrointestinal disorders
Dry Mouth
|
8.0%
4/50 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
14.0%
7/50 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
8.0%
4/50 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.0%
13/50 • Number of events 19
|
|
Blood and lymphatic system disorders
Edema
|
12.0%
6/50 • Number of events 6
|
|
Investigations
Fatigue
|
48.0%
24/50 • Number of events 42
|
|
Investigations
Fever
|
16.0%
8/50 • Number of events 10
|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
6/50 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemorrhage: Nose
|
18.0%
9/50 • Number of events 11
|
|
Blood and lymphatic system disorders
Hemorrhage: Pulmonary
|
8.0%
4/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
14.0%
7/50 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.0%
9/50 • Number of events 13
|
|
Cardiac disorders
Hypertension
|
12.0%
6/50 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
10/50 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.0%
3/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.0%
6/50 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.0%
11/50 • Number of events 13
|
|
Cardiac disorders
Hypotension
|
6.0%
3/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Infection: Lung (pneumonia)
|
14.0%
7/50 • Number of events 7
|
|
Renal and urinary disorders
Infection: Urinary Tract
|
12.0%
6/50 • Number of events 10
|
|
Blood and lymphatic system disorders
Lymphopenia
|
18.0%
9/50 • Number of events 10
|
|
Nervous system disorders
Mood Alteration: Anxiety
|
16.0%
8/50 • Number of events 8
|
|
Nervous system disorders
Mood Alteration: Depression
|
10.0%
5/50 • Number of events 6
|
|
Gastrointestinal disorders
Mucositis
|
24.0%
12/50 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
16.0%
8/50 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
6.0%
3/50 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
42.0%
21/50 • Number of events 32
|
|
Gastrointestinal disorders
Pain: Abdominal
|
14.0%
7/50 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
10.0%
5/50 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pain: Chest
|
16.0%
8/50 • Number of events 10
|
|
Nervous system disorders
Pain: Headache
|
8.0%
4/50 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain: Musculoskeletal Limb
|
28.0%
14/50 • Number of events 17
|
|
Blood and lymphatic system disorders
Platelets: Decreased
|
14.0%
7/50 • Number of events 11
|
|
Metabolism and nutrition disorders
Proteinuria
|
12.0%
6/50 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Rash
|
86.0%
43/50 • Number of events 76
|
|
Skin and subcutaneous tissue disorders
Rash: Hand/Foot
|
10.0%
5/50 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
6.0%
3/50 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
10.0%
5/50 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum Bicarbonate Decreased
|
10.0%
5/50 • Number of events 5
|
|
Gastrointestinal disorders
Taste Alteration (dysgeusia)
|
18.0%
9/50 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
26.0%
13/50 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
11/50 • Number of events 15
|
|
Investigations
Weight Loss
|
32.0%
16/50 • Number of events 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place