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

March 13, 2015 updated by: DuNan, Chinese PLA General Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • PLA 304 hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab & Cisplatin
Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks
Drug: Bevacizumab
Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week
Other Names:
  • Avastin
Drug: Cisplatin
Cisplatin 30mg,intrapleural administration,each 2 week
Active Comparator: Cisplatin
Cisplatin 30mg by intrapleural given every two weeks
Drug: Cisplatin
Cisplatin 30mg,intrapleural administration,each 2 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With "Complete Response" and "Partial Response"
Time Frame: 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
from randomization, This treatment was given every two weeks,responses were made by biweekly

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)
Time Frame: before intrapleural administration
before intrapleural administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Nan Du, PLA 304 hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 25, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 10, 2012

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLA304DN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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