Trial Outcomes & Findings for A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE) (NCT NCT00318136)

Last Updated: 2010-05-11

Results Overview

To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

Results posted on

2010-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treated With Bevacizumab Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Overall Study STARTED	47
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated With Bevacizumab n=31 Participants Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Age Continuous	65.0 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

Population: Safety-evaluable patients

Outcome measures

Outcome measures
Measure	Treated With Bevacizumab n=31 Participants Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events	3.2 Percentage of patients

SECONDARY outcome

Timeframe: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

Population: Safety-evaluable patients

Selected treatment-emergent adverse events for any grade of pulmonary hemorrhage, any grade of non-pulmonary hemorrhage, any grade of gastrointestinal perforation, Grade ≥ 2 arterial thromboembolic events, Grade ≥ 2 left ventricular systolic dysfunction, Grade ≥ 3 proteinuria, and Grade ≥ 3 hypertension. Refer to NCI CTCAE v.3 for grading definitions. Serious adverse events (SAEs) occurring in any of the above categories are included. See the Serious Adverse Events section below for full SAE reporting.

Outcome measures

Outcome measures
Measure	Treated With Bevacizumab n=31 Participants Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Selected Adverse Events Any grade of pulmonary hemorrhage	2 Patients
Selected Adverse Events Any grade of non-pulmonary hemorrhage	0 Patients
Selected Adverse Events Any grade of gastrointestinal perforation	0 Patients
Selected Adverse Events Grade ≥ 2 arterial thromboembolic events	2 Patients
Selected Adverse Events Grade ≥ 2 left ventricular systolic dysfunction	1 Patients
Selected Adverse Events Grade ≥ 3 proteinuria	1 Patients
Selected Adverse Events Grade ≥ 3 hypertension	5 Patients

SECONDARY outcome

Timeframe: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death

Population: Safety-evaluable patients

Any treatment-emergent adverse event leading to study treatment discontinuation

Outcome measures

Outcome measures
Measure	Treated With Bevacizumab n=31 Participants Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Adverse Events That Led to Discontinuation of Bevacizumab Cerebral Infarction	1 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Cerebral Ischemia	1 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Neuropathy Peripheral	1 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Deep Vein Thrombosis	2 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Hypertension	1 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Dyspnea	1 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Pulmonary Embolism	1 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Cardiac Failure Congestive	1 Patients
Adverse Events That Led to Discontinuation of Bevacizumab Proteinuria	1 Patients

SECONDARY outcome

Timeframe: Length of study

Population: Enrolled patients

Progression-free survival (PFS) was defined as the time from enrollment to the time of documented disease progression or death from any cause, whichever occurred earlier. PFS was determined for only those patients that received bevacizumab. Summary of PFS (median) was estimated from Kaplan-Meier curve. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Outcome measures
Measure	Treated With Bevacizumab n=31 Participants Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Progression-free Survival	6.2 Months Interval 5.32 to 7.62

Adverse Events

Treated With Bevacizumab

Serious events: 18 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treated With Bevacizumab n=31 participants at risk Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Respiratory, thoracic and mediastinal disorders Dyspnea	12.9% 4/31
Respiratory, thoracic and mediastinal disorders Hemoptysis	3.2% 1/31
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	3.2% 1/31
Respiratory, thoracic and mediastinal disorders Pulmonary Hemorrhage	3.2% 1/31
Infections and infestations Bronchitis	3.2% 1/31
Infections and infestations Infection	3.2% 1/31
Infections and infestations Pneumonia	3.2% 1/31
Nervous system disorders Basal Ganglia Infarction	3.2% 1/31
Nervous system disorders Cerebral Infarction	3.2% 1/31
Nervous system disorders Cerebral Ischemia	3.2% 1/31
Vascular disorders Deep Vein Thrombosis	6.5% 2/31
Vascular disorders Hypotension	3.2% 1/31
Cardiac disorders Atrial Flutter	3.2% 1/31
Cardiac disorders Cardiac Failure Congestive	3.2% 1/31
Gastrointestinal disorders Small Intestinal Obstruction	3.2% 1/31
General disorders Pain	3.2% 1/31
Injury, poisoning and procedural complications Hip Fracture	3.2% 1/31
Psychiatric disorders Confusional State	3.2% 1/31

Other adverse events

Other adverse events
Measure	Treated With Bevacizumab n=31 participants at risk Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
Vascular disorders Hypertension	19.4% 6/31
General disorders Asthenia	3.2% 1/31
General disorders Chest Pain	3.2% 1/31
General disorders Chills	3.2% 1/31
General disorders Fatigue	3.2% 1/31
General disorders Pyrexia	3.2% 1/31
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 2/31
Nervous system disorders Neuropathy Peripheral	6.5% 2/31
Infections and infestations Sinusitis	3.2% 1/31
Metabolism and nutrition disorders Anorexia	3.2% 1/31
Renal and urinary disorders Proteinuria	3.2% 1/31
Respiratory, thoracic and mediastinal disorders Hemoptysis	3.2% 1/31

Additional Information

Medical Communications

Genentech, Inc.

Phone: 800-821-8590

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER