Trial Outcomes & Findings for Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer (NCT NCT01661790)

Results Overview

Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when \>50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

72 participants

Primary outcome timeframe

from randomization, This treatment was given every two weeks,responses were made by biweekly

Results posted on

2015-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab & Cisplatin Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg\&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week	Cisplatin Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W
Overall Study STARTED	36	36
Overall Study COMPLETED	36	34
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Bevacizumab & Cisplatin Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg\&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week	Cisplatin Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab & Cisplatin n=36 Participants Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg\&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W	Cisplatin n=34 Participants Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical >=65 years	20 Participants n=93 Participants	18 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants

PRIMARY outcome

Timeframe: from randomization, This treatment was given every two weeks,responses were made by biweekly

Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when \>50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR

Outcome measures

Outcome measures
Measure	Bevacizumab & Cisplatin n=36 Participants Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg\&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W	Cisplatin n=34 Participants Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W
Number of Participants With "Complete Response" and "Partial Response" PR	13 participants	15 participants
Number of Participants With "Complete Response" and "Partial Response" CR	17 participants	2 participants

SECONDARY outcome

Timeframe: baseline to biweekly,until disease progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: randomization to four weeks,until death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 month after the last treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline to biweekly,until death

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: before intrapleural administration

Outcome measures

Outcome data not reported

Adverse Events

Bevacizumab & Cisplatin

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Cisplatin

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bevacizumab & Cisplatin n=36 participants at risk Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks Bevacizumab: Bevacizumab300mg\&Cisplatin 30mg by intrapleural administration of each 2 week Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W	Cisplatin n=36 participants at risk Cisplatin 30mg by intrapleural given every two weeks Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W
Blood and lymphatic system disorders Leucocytopenia	66.7% 24/36 • Number of events 24	61.1% 22/36 • Number of events 22

Additional Information

Dr. Nan Du

China PLA General Hospital

Phone: 86-13911599657

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place