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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
DuNan, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01661790
First received: July 25, 2012
Last updated: March 13, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Malignant Pleural Effusion
Drug: Bevacizumab
Drug: Cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Median Progression Free Survival (PFS) [ Time Frame: baseline to biweekly,until disease progression ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: randomization to four weeks,until death ] [ Designated as safety issue: No ]
  • Adverse Reactions [ Time Frame: Up to 1 month after the last treatment ] [ Designated as safety issue: Yes ]
  • Qualify of Life (QoL) [ Time Frame: baseline to biweekly,until death ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A) [ Time Frame: before intrapleural administration ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: August 2009
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Cisplatin
Active Comparator: Cisplatin
Cisplatin 30mg by intrapleural given every two weeks
Drug: Cisplatin
Cisplatin 30mg,intrapleural administration,each 2 week
Other Name: Cisplatin

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 25, 2012
Results First Received: February 16, 2015
Last Updated: March 13, 2015
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2015