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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 3

Conditions: Malignant Pleural Effusion

Treatments: Drug: Bevacizumab; Drug: Cisplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01661790

PLA304DN-001

Details and patient eligibility

About

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).

Enrollment: 72 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Bevacizumab & Cisplatin

Experimental group

Description:

Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks

Treatment:

Drug: Cisplatin

Drug: Bevacizumab

Cisplatin

Active Comparator group

Description:

Cisplatin 30mg by intrapleural given every two weeks

Treatment:

Drug: Cisplatin