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

Phase 3

Completed

• Conditions: Malignant Pleural Effusion
• Interventions: Drug: Bevacizumab; Drug: Cisplatin

• Registration Number: NCT01661790
• Lead Sponsor: Chinese PLA General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2012-06
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-10
• Study Completion: 2012-10
• Results First Submitted: 2015-02-16
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-13
• Last Update Submitted: 2015-03-13
• Results First Posted: 2015-03-25
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab & Cisplatin	Bevacizumab	Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Bevacizumab & Cisplatin	Cisplatin	Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Cisplatin	Cisplatin	Cisplatin 30mg by intrapleural given every two weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Median Progression Free Survival (PFS)	baseline to biweekly,until disease progression
Adverse Reactions	Up to 1 month after the last treatment
Qualify of Life (QoL)	baseline to biweekly,until death
Overall Survival (OS)	randomization to four weeks,until death

Trial Locations

Locations (1)

PLA 304 hospital; 🇨🇳 Beijing, Beijing, China