Phase 3 N=72 Randomized Treatment

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

Malignant Pleural Effusion

Bottom Line

View on ClinicalTrials.gov: NCT01661790 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Number of Participants With "Complete Response" and "Partial Response" — 17; 2; 13; 15 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Bevacizumab (Drug); Cisplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Chinese PLA General Hospital
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With "Complete Response" and "Partial Response"	17; 2; 13; 15	—
SECONDARY Median Progression Free Survival (PFS)	—	—
SECONDARY Overall Survival (OS)	—	—
SECONDARY Adverse Reactions	—	—
SECONDARY Qualify of Life (QoL)	—	—

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01661790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.