Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
Primary Purpose
Malignant Pleural Effusion
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring Bevacizumab;, non-small cell lung cancer;, malignant pleural effusion;, intrapleural administration
Eligibility Criteria
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.
Sites / Locations
- PLA 304 hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bevacizumab & Cisplatin
Cisplatin
Arm Description
Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Cisplatin 30mg by intrapleural given every two weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Median Progression Free Survival (PFS)
Overall Survival (OS)
Adverse Reactions
Qualify of Life (QoL)
Full Information
NCT ID
NCT01661790
First Posted
July 25, 2012
Last Updated
March 13, 2015
Sponsor
Chinese PLA General Hospital
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT01661790
Brief Title
Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
Official Title
Open-labeled, Randomized, Multicenter Phase III Study of Adjuvant Chemotherapy Comparing Bevacizumab Plus Cisplatin With Cisplatin Regimen in Malignant Pleural Effusion of Advanced Stage Non-Small-Cell Lung Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Roche Pharma AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
Keywords
Bevacizumab;, non-small cell lung cancer;, malignant pleural effusion;, intrapleural administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab & Cisplatin
Arm Type
Experimental
Arm Description
Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Arm Title
Cisplatin
Arm Type
Active Comparator
Arm Description
Cisplatin 30mg by intrapleural given every two weeks
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin 30mg,intrapleural administration,each 2 week
Primary Outcome Measure Information:
Title
Number of Participants With "Complete Response" and "Partial Response"
Description
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
Secondary Outcome Measure Information:
Title
Median Progression Free Survival (PFS)
Time Frame
baseline to biweekly,until disease progression
Title
Overall Survival (OS)
Time Frame
randomization to four weeks,until death
Title
Adverse Reactions
Time Frame
Up to 1 month after the last treatment
Title
Qualify of Life (QoL)
Time Frame
baseline to biweekly,until death
Other Pre-specified Outcome Measures:
Title
Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)
Time Frame
before intrapleural administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Du
Organizational Affiliation
PLA 304 hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
PLA 304 hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
12. IPD Sharing Statement
Learn more about this trial
Intrapleural Bevacizumab and Cisplatin Therapy for Malignant Pleural Effusion Caused by Non-small Cell Lung Cancer
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