NCT01661790

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 25, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

July 25, 2012

Results QC Date

February 16, 2015

Last Update Submit

March 13, 2015

Conditions

Malignant Pleural Effusion

Keywords

Bevacizumab;non-small cell lung cancer;malignant pleural effusion;intrapleural administration

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Median Progression Free Survival (PFS)

    baseline to biweekly,until disease progression

  • Overall Survival (OS)

    randomization to four weeks,until death

  • Adverse Reactions

    Up to 1 month after the last treatment

  • Qualify of Life (QoL)

    baseline to biweekly,until death

Other Outcomes (1)

  • Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)

    before intrapleural administration

Study Arms (2)

Bevacizumab & Cisplatin

EXPERIMENTAL

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

Drug: BevacizumabDrug: Cisplatin

Cisplatin

ACTIVE COMPARATOR

Cisplatin 30mg by intrapleural given every two weeks

Drug: Cisplatin

Interventions

BevacizumabDRUG

Bevacizumab300mg\&Cispltin30mg by intrapleural administration of each 2 week

Also known as: Avastin
Bevacizumab & Cisplatin
CisplatinDRUG

Cisplatin 30mg,intrapleural administration,each 2 week

Bevacizumab & CisplatinCisplatin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active thoracic cavity or systemic bleeding
  • Active pleural or systemic infection.
  • Known sensitivity to Bevacizumab or Cisplatin
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA 304 hospital

Beijing, Beijing Municipality, 100048, China

Location

MeSH Terms

Conditions

Pleural Effusion, MalignantCarcinoma, Non-Small-Cell Lung

Interventions

BevacizumabCisplatin

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsLung Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Results Point of Contact

Title
Dr. Nan Du
Organization
China PLA General Hospital
dunan05@aliyun.com
86-13911599657

Study Officials

  • Nan Du

    PLA 304 hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of oncology department in PLA 304 hospital

Study Record Dates

First Submitted

July 25, 2012

First Posted

August 10, 2012

Study Start

August 1, 2009

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

March 25, 2015

Results First Posted

March 25, 2015

Record last verified: 2015-03

Locations

CN(1)