Trial Outcomes & Findings for Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer (NCT NCT00367601)
NCT ID: NCT00367601
Last Updated: 2016-02-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
4 months
Results posted on
2016-02-11
Participant Flow
Participant milestones
| Measure |
Single Arm Assignment
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib + Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Single Arm Assignment
n=25 Participants
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1
|
|---|---|
|
Age, Customized
Median Age, Years
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 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
|
25 participants
n=5 Participants
|
|
Investigator Assigned Performance Status
Performance Status 1
|
2 participants
n=5 Participants
|
|
Investigator Assigned Performance Status
Performance Status 2
|
23 participants
n=5 Participants
|
|
Patient-Reported Performance Status
Performance Status 1
|
8 participants
n=5 Participants
|
|
Patient-Reported Performance Status
Performance Status 2
|
13 participants
n=5 Participants
|
|
Patient-Reported Performance Status
Performance Status 3
|
2 participants
n=5 Participants
|
|
Patient-Reported Performance Status
Performance Status Missing
|
2 participants
n=5 Participants
|
|
Smoking Status
Never Smoked
|
1 participants
n=5 Participants
|
|
Smoking Status
Not smoked in > 30 years
|
4 participants
n=5 Participants
|
|
Smoking Status
Quit > 3 months ago but <30 years ago
|
10 participants
n=5 Participants
|
|
Smoking Status
Current smoker
|
9 participants
n=5 Participants
|
|
Smoking Status
Unknown
|
1 participants
n=5 Participants
|
|
Stage
Stage III-B
|
3 participants
n=5 Participants
|
|
Stage
Stage IV
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsOutcome measures
| Measure |
Single Arm
n=25 Participants
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
|
|---|---|
|
To Establish Rate of Non-progressive Disease at 4 Months in Patients With Advanced NSCLC Who Have Been Designated PS2 by Their Treating Physician
|
28 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Single Arm
n=25 Participants
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
|
|---|---|
|
Time to Progression
|
3.4 months
Interval 1.3 to 5.4
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Single Arm
n=25 Participants
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
|
|---|---|
|
Overall Survival
|
5.1 months
Interval 3.3 to 8.3
|
Adverse Events
Single Arm Assignment
Serious events: 16 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Assignment
n=25 participants at risk
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS)
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
12.0%
3/25 • Number of events 3
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
DEHYDRATION
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
16.0%
4/25 • Number of events 4
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
4.0%
1/25 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
4.0%
1/25 • Number of events 1
|
|
General disorders
PAIN / BACK
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
ULCER, GI / DUODENUM
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Single Arm Assignment
n=25 participants at risk
Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
Erlotinib: Erlotinib 150 mg qd days 1-21
Bevacizumab: Bevacizumab 15 mg/kg IV, day 1
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
4.0%
1/25 • Number of events 1
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
ANOREXIA
|
44.0%
11/25 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS (NON-SEPTIC)
|
4.0%
1/25 • Number of events 1
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
CARDIAC GENERAL - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
20.0%
5/25 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
40.0%
10/25 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHEA
|
44.0%
11/25 • Number of events 16
|
|
Nervous system disorders
DIZZINESS
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
28.0%
7/25 • Number of events 8
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
16.0%
4/25 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
EXTREMITY-LOWER (GAIT/WALKING)
|
4.0%
1/25 • Number of events 1
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
44.0%
11/25 • Number of events 16
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
8.0%
2/25 • Number of events 2
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
12.0%
3/25 • Number of events 3
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
12.0%
3/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
HICCOUGHS (HICCUPS, SINGULTUS)
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
HYPOTENSION
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
12.0%
3/25 • Number of events 4
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / ABDOMEN NOS
|
8.0%
2/25 • Number of events 2
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / SKIN (CELLULITES)
|
8.0%
2/25 • Number of events 2
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
8.0%
2/25 • Number of events 3
|
|
Psychiatric disorders
MOOD ALTERATION / AGITATION
|
8.0%
2/25 • Number of events 2
|
|
Psychiatric disorders
MOOD ALTERATION / ANXIETY
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
16.0%
4/25 • Number of events 4
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
16.0%
4/25 • Number of events 8
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / EXTREMITY-LOWER
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) / WHOLE BODY/GENERALIZED
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __)
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
24.0%
6/25 • Number of events 7
|
|
Nervous system disorders
NEUROLOGY - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY: MOTOR
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
8.0%
2/25 • Number of events 2
|
|
Eye disorders
OCULAR SURFACE DISEASE
|
4.0%
1/25 • Number of events 1
|
|
Eye disorders
OCULAR/VISUAL - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
4.0%
1/25 • Number of events 1
|
|
General disorders
PAIN / BACK
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / BONE
|
12.0%
3/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST WALL
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
4.0%
1/25 • Number of events 1
|
|
General disorders
PAIN / FACE
|
4.0%
1/25 • Number of events 1
|
|
General disorders
PAIN / HEAD/HEADACHE
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
4.0%
1/25 • Number of events 1
|
|
General disorders
PAIN / NECK
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PAIN / SKIN
|
4.0%
1/25 • Number of events 1
|
|
General disorders
PAIN / TUMOR PAIN
|
4.0%
1/25 • Number of events 1
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1
|
|
Endocrine disorders
PANCREATIC ENDOCRINE: GLUCOSE INTOLERANCE
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
4.0%
1/25 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
12.0%
3/25 • Number of events 3
|
|
Investigations
PROTEINURIA
|
16.0%
4/25 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
12.0%
3/25 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
40.0%
10/25 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
8.0%
2/25 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
SKIN BREAKDOWN/DECUBITUS ULCER
|
4.0%
1/25 • Number of events 1
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
4.0%
1/25 • Number of events 2
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
VASCULAR - OTHER (SPECIFY, __)
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
8.0%
2/25 • Number of events 2
|
|
General disorders
WEIGHT GAIN
|
4.0%
1/25 • Number of events 1
|
|
General disorders
WEIGHT LOSS
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
WOUND COMPLICATION, NON-INFECTIOUS
|
4.0%
1/25 • Number of events 3
|
Additional Information
Principal Investigator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place