Trial Outcomes & Findings for Phase 2 Trial of Bevacizumab in Combination With Pemetrexed (NCT NCT00227019)
NCT ID: NCT00227019
Last Updated: 2017-03-06
Results Overview
Number of events of brain or central nervous system (CNS) bleeding
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
18 months
Results posted on
2017-03-06
Participant Flow
Participant milestones
| Measure |
Bevacizumab Plus Pemetrexed
Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Trial of Bevacizumab in Combination With Pemetrexed
Baseline characteristics by cohort
| Measure |
Bevacizumab Plus Pemetrexed
n=16 Participants
Treatment group is adult patients with metastatic nonsquamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 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
|
10 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
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0-1
|
15 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
2
|
1 participants
n=5 Participants
|
|
Histology
Adeno-carcinoma
|
12 participants
n=5 Participants
|
|
Histology
Large cell carinoma
|
0 participants
n=5 Participants
|
|
Histology
Not otherwise specified (NOS)
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All participants in this study are included in the analysis population
Number of events of brain or central nervous system (CNS) bleeding
Outcome measures
| Measure |
Bevacizumab + Pemetrexed
n=16 Participants
Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
|
|---|---|
|
Incidence of Central Nervous System (CNS) Hemorrhagic Events
|
0 CNS hemorrhagic events
|
SECONDARY outcome
Timeframe: 18 monthsProgression-free survival (PFS) is defined as the duration of time from start of treatment to time of documented disease progression or death. Kaplan-Meier survival curves for PFS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL).
Outcome measures
| Measure |
Bevacizumab + Pemetrexed
n=16 Participants
Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
|
|---|---|
|
Progression-free Survival (PFS)
|
7.2 months
Interval 5.5 to 9.0
|
SECONDARY outcome
Timeframe: 18 monthsOverall Survival (OS) is defined as the duration of time from start of treatment to deat. Kaplan-Meier survival curves for OS were generated with IBM SPSS Statistics version 19.0 (SPSS, Inc, Chicago, IL).
Outcome measures
| Measure |
Bevacizumab + Pemetrexed
n=16 Participants
Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
|
|---|---|
|
Overall Survival (OS)
|
14.8 months
Interval 9.4 to 21.0
|
Adverse Events
Bevacizumab Plus Pemetrexed
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab Plus Pemetrexed
n=16 participants at risk
Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
|
|---|---|
|
General disorders
Infection
|
37.5%
6/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea/ respiratory distress
|
12.5%
2/16 • 18 Months
|
|
General disorders
Fatigue
|
18.8%
3/16 • 18 Months
|
|
Blood and lymphatic system disorders
Neutropenia +/- fever
|
18.8%
3/16 • 18 Months
|
|
Blood and lymphatic system disorders
Elevated creatinine/ Actue Renal failure (ARF)
|
6.2%
1/16 • 18 Months
|
|
Blood and lymphatic system disorders
Thrombosis/ deep vein thrombosis (DVT)
|
12.5%
2/16 • 18 Months
|
|
General disorders
Confusion
|
6.2%
1/16 • 18 Months
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
6.2%
1/16 • 18 Months
|
|
Blood and lymphatic system disorders
Hyponatremia
|
6.2%
1/16 • 18 Months
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.2%
1/16 • 18 Months
|
|
General disorders
Pain
|
6.2%
1/16 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Seizure-like activity
|
6.2%
1/16 • 18 Months
|
|
Blood and lymphatic system disorders
Syncope
|
6.2%
1/16 • 18 Months
|
|
General disorders
Weight gain
|
6.2%
1/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.2%
1/16 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.2%
1/16 • 18 Months
|
Other adverse events
| Measure |
Bevacizumab Plus Pemetrexed
n=16 participants at risk
Treatment group is adult patients with metastatic non squamous, non-small cell lung cancer (NSCLC) and stable brain metastases after progression on a platinum doublet regimen for advanced disease. All patients received pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV) every 3 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
6.2%
1/16 • 18 Months
|
|
Endocrine disorders
Adrenal insufficiency
|
6.2%
1/16 • 18 Months
|
|
Immune system disorders
Allergic reaction
|
6.2%
1/16 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
1/16 • 18 Months
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • 18 Months
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
1/16 • 18 Months
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
2/16 • 18 Months
|
|
Eye disorders
Blurred vision
|
18.8%
3/16 • 18 Months
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • 18 Months
|
|
Infections and infestations
Catheter related infection
|
6.2%
1/16 • 18 Months
|
|
Infections and infestations
Skin infection
|
6.2%
1/16 • 18 Months
|
|
General disorders
Chills
|
6.2%
1/16 • 18 Months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
12.5%
2/16 • 18 Months
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
31.2%
5/16 • 18 Months
|
|
Investigations
Creatinine increased
|
12.5%
2/16 • 18 Months
|
|
Metabolism and nutrition disorders
Creatinine increased
|
50.0%
8/16 • 18 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
8/16 • 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • 18 Months
|
|
Gastrointestinal disorders
Dental caries
|
6.2%
1/16 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
6.2%
1/16 • 18 Months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • 18 Months
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
8/16 • 18 Months
|
|
General disorders
Localized edema
|
12.5%
2/16 • 18 Months
|
|
General disorders
Edema limbs
|
12.5%
2/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
37.5%
6/16 • 18 Months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
1/16 • 18 Months
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
1/16 • 18 Months
|
|
General disorders
Fatigue
|
68.8%
11/16 • 18 Months
|
|
General disorders
Fever
|
18.8%
3/16 • 18 Months
|
|
General disorders
Gait disturbance
|
6.2%
1/16 • 18 Months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
6.2%
1/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
18.8%
3/16 • 18 Months
|
|
Ear and labyrinth disorders
Hearing impaired
|
6.2%
1/16 • 18 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
6.2%
1/16 • 18 Months
|
|
Vascular disorders
Hot flashes
|
12.5%
2/16 • 18 Months
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • 18 Months
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • 18 Months
|
|
General disorders
Injection site reaction
|
6.2%
1/16 • 18 Months
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • 18 Months
|
|
Gastrointestinal disorders
Periodontal disease
|
6.2%
1/16 • 18 Months
|
|
Nervous system disorders
Amnesia
|
6.2%
1/16 • 18 Months
|
|
Psychiatric disorders
Agitation
|
12.5%
2/16 • 18 Months
|
|
Gastrointestinal disorders
Mucositis oral
|
6.2%
1/16 • 18 Months
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • 18 Months
|
|
Investigations
Neutrophil count decreased
|
6.2%
1/16 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
1/16 • 18 Months
|
|
General disorders
Pain
|
75.0%
12/16 • 18 Months
|
|
Gastrointestinal disorders
Pancreatitis
|
6.2%
1/16 • 18 Months
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
1/16 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
18.8%
3/16 • 18 Months
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
2/16 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.2%
1/16 • 18 Months
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • 18 Months
|
|
Nervous system disorders
Depressed level of consciousness
|
6.2%
1/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
1/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
1/16 • 18 Months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, transiminitis
|
6.2%
1/16 • 18 Months
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • 18 Months
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
1/16 • 18 Months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.2%
1/16 • 18 Months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
6.2%
1/16 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
6.2%
1/16 • 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • 18 Months
|
|
Investigations
Weight loss
|
25.0%
4/16 • 18 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place