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

Malignant Pleural Effusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661790
• Other study ID #: PLA304DN-001
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2012
• Last updated: March 13, 2015
• Start date: August 2009
• Est. completion date: October 2012

Study information

• Verified date: March 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• Bevacizumab
Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week
• Cisplatin
Cisplatin 30mg,intrapleural administration,each 2 week

Locations

Country	Name	City	State
China	PLA 304 hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Roche Pharma AG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)		before intrapleural administration	No
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	from randomization, This treatment was given every two weeks,responses were made by biweekly	No
Secondary	Median Progression Free Survival (PFS)		baseline to biweekly,until disease progression	No
Secondary	Overall Survival (OS)		randomization to four weeks,until death	No
Secondary	Adverse Reactions		Up to 1 month after the last treatment	Yes
Secondary	Qualify of Life (QoL)		baseline to biweekly,until death	No