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OpenTrials
Completed

NCT Number: NCT01661790

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

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).

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Key information

Conditions

Malignant Pleural Effusion Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

PLA 304 hospital

Beijing, Beijing Municipality, 100048, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab

Drug

Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week

Other names: Avastin

Cisplatin

Drug

Cisplatin 30mg,intrapleural administration,each 2 week

Primary outcomes

  1. 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

Secondary outcomes

  1. Median Progression Free Survival (PFS)

    Time frame: baseline to biweekly,until disease progression

  2. Overall Survival (OS)

    Time frame: randomization to four weeks,until death

  3. Adverse Reactions

    Time frame: Up to 1 month after the last treatment

  4. Qualify of Life (QoL)

    Time frame: baseline to biweekly,until death

Other outcomes

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

    Time frame: before intrapleural administration

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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