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

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ClinicalTrials.gov Identifier: NCT01661790
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : March 25, 2015
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Drug: Bevacizumab Drug: Cisplatin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2009
Primary Completion Date : June 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

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 Name: 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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A) [ Time Frame: before intrapleural administration ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661790


Locations
China, Beijing
PLA 304 hospital
Beijing, Beijing, China, 100048
Sponsors and Collaborators
Chinese PLA General Hospital
Roche Pharma AG
Investigators
Principal Investigator: Nan Du PLA 304 hospital
More Information

Responsible Party: DuNan, director of oncology department in PLA 304 hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01661790     History of Changes
Other Study ID Numbers: PLA304DN-001
First Posted: August 10, 2012    Key Record Dates
Results First Posted: March 25, 2015
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by DuNan, Chinese PLA General Hospital:
Bevacizumab;
non-small cell lung cancer;
malignant pleural effusion;
intrapleural administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pleural Effusion
Pleural Effusion, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pleural Diseases
Pleural Neoplasms
Cisplatin
Bevacizumab
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors