Trial Outcomes & Findings for Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer (NCT NCT00553800)
NCT ID: NCT00553800
Last Updated: 2022-07-12
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
3 years
Results posted on
2022-07-12
Participant Flow
Participant milestones
| Measure |
Bevacizumab & Erlotinib
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
bevacizumab
Erlotinib
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab & Erlotinib
n=32 Participants
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
bevacizumab
Erlotinib
|
|---|---|
|
Age, Customized
≤ 75 yrs
|
18 Participants
n=5 Participants
|
|
Age, Customized
> 75 yrs
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Bevacizumab & Erlotinib
n=32 Participants
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
bevacizumab
Erlotinib
|
|---|---|
|
Progression Free Survival (PFS)
|
6.6 months
Interval 3.2 to 12.0
|
Adverse Events
Bevacizumab & Erlotinib
Serious events: 15 serious events
Other events: 32 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Bevacizumab & Erlotinib
n=32 participants at risk
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
bevacizumab
Erlotinib
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
9.4%
3/32 • 3 years
|
|
Metabolism and nutrition disorders
FTT
|
3.1%
1/32 • 3 years
|
|
General disorders
Pain
|
9.4%
3/32 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
3.1%
1/32 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
3.1%
1/32 • 3 years
|
|
Metabolism and nutrition disorders
Anemia
|
3.1%
1/32 • 3 years
|
|
Psychiatric disorders
Confusion
|
6.2%
2/32 • 3 years
|
|
General disorders
Fatigue
|
3.1%
1/32 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.1%
1/32 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
2/32 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.2%
2/32 • 3 years
|
|
Gastrointestinal disorders
Bowel perforation
|
3.1%
1/32 • 3 years
|
|
Cardiac disorders
Hypoxia
|
3.1%
1/32 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • 3 years
|
Other adverse events
| Measure |
Bevacizumab & Erlotinib
n=32 participants at risk
bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
bevacizumab
Erlotinib
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
28.1%
9/32 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
6/32 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
12/32 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
31.2%
10/32 • 3 years
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
8/32 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.6%
13/32 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
9.4%
3/32 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry cracked skin
|
25.0%
8/32 • 3 years
|
|
Skin and subcutaneous tissue disorders
Fissures
|
6.2%
2/32 • 3 years
|
|
Skin and subcutaneous tissue disorders
Incr. hair growth
|
9.4%
3/32 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.6%
5/32 • 3 years
|
|
General disorders
Fatigue
|
31.2%
10/32 • 3 years
|
|
Metabolism and nutrition disorders
Weight loss
|
21.9%
7/32 • 3 years
|
|
Psychiatric disorders
Depression
|
21.9%
7/32 • 3 years
|
|
Nervous system disorders
Neuropathy
|
21.9%
7/32 • 3 years
|
|
Vascular disorders
Hypertension
|
28.1%
9/32 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
8/32 • 3 years
|
|
Vascular disorders
Deep vein thrmbosis
|
3.1%
1/32 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place