Malignant Pleural Effusion
Conditions
Keywords
Bevacizumab;, non-small cell lung cancer;, malignant pleural effusion;, intrapleural administration
Brief summary
To determine the efficacy and Safety of intrapleural Bevacizumab and cisplatin as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).
Interventions
DRUGBevacizumab
Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week
DRUGCisplatin
Cisplatin 30mg,intrapleural administration,each 2 week
Sponsors
Roche Pharma AG
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with advanced recurrent or progressive NSCLC proven cytohistologically * Karnofsky performance status (KPS) ≥60 * Life expectancy ≥ 2 months * No history of severe diseases of major organs including liver, heart, and kidney * No previous intrapleural therapy * Written informed consent
Exclusion criteria
* Active thoracic cavity or systemic bleeding * Active pleural or systemic infection. * Known sensitivity to Bevacizumab or Cisplatin * Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Response and Partial Response | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Median Progression Free Survival (PFS) | baseline to biweekly,until disease progression |
| Overall Survival (OS) | randomization to four weeks,until death |
| Adverse Reactions | Up to 1 month after the last treatment |
| Qualify of Life (QoL) | baseline to biweekly,until death |
Other
| Measure | Time frame |
|---|---|
| Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A) | before intrapleural administration |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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,Q2W | 36 |
| Cisplatin Cisplatin 30mg by intrapleural given every two weeks
Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W | 34 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Bevacizumab & Cisplatin | Cisplatin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 18 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 36 | 22 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
Primary
Number of Participants With Complete Response and Partial Response
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
Time frame: from randomization, This treatment was given every two weeks,responses were made by biweekly
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab & Cisplatin | Number of Participants With Complete Response and Partial Response | CR | 17 participants |
| Bevacizumab & Cisplatin | Number of Participants With Complete Response and Partial Response | PR | 13 participants |
| Cisplatin | Number of Participants With Complete Response and Partial Response | CR | 2 participants |
| Cisplatin | Number of Participants With Complete Response and Partial Response | PR | 15 participants |
Secondary
Adverse Reactions
Time frame: Up to 1 month after the last treatment
Secondary
Median Progression Free Survival (PFS)
Time frame: baseline to biweekly,until disease progression
Secondary
Overall Survival (OS)
Time frame: randomization to four weeks,until death
Secondary
Qualify of Life (QoL)
Time frame: baseline to biweekly,until death
Other Pre-specified
Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)
Time frame: before intrapleural administration