Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion

• ClinicalTrials.gov Identifier: NCT02054078
• Recruitment Status: Unknown
• First Posted: February 4, 2014
• Last Update Posted: February 4, 2014
• Sponsor: Tang-Du Hospital
• Information provided by (Responsible Party): Xiaofei Li, Tang-Du Hospital

Tracking Information

• First Submitted Date: January 28, 2014
• First Posted Date: February 4, 2014
• Last Update Posted Date: February 4, 2014
• Study Start Date: January 2012
• Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 3, 2014)

Changes in chest drainage [ Time Frame: up to 3months ]

Observed chest drainage every day

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 3, 2014)

• the average daily VAS defining breathlessness [ Time Frame: up to 1 year ]
  VAS: Visual Analogue Scale
• Average daily thoracalgia assessed using VAS score [ Time Frame: up to 1 year ]
  VAS: Visual Analogue Scale
• percentage of adverse reactions [ Time Frame: up to 1 year ]
• Length of Stay [ Time Frame: up to 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
• Official Title: Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study
• Brief Summary: Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Detailed Description

Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Methods:

A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Malignant Pleural Effusion

Intervention

• Drug: Bevacizumab
  Bevacizumab200mg by intrapleural administration
  Other Name: Avastin
• Drug: Pulvis talci
  Pulvis talci 4g by intrapleural administration

Study Arms

• Experimental: Bevacizumab
  Bevacizumab200mg by intrapleural administration
  Intervention: Drug: Bevacizumab
• Active Comparator: Pulvis talci
  Pulvis talci 4g by intrapleural administration
  Intervention: Drug: Pulvis talci

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 3, 2014): 183
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Diagnose malignant pleural effusions by:

   • Diagnose malignant pleural neoplasms by histopathology
   • Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
2. Written informed consent

Exclusion Criteria:

1. <18years of age
2. Expected survival <3 months
3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
4. Planned chemotherapy
5. Pregnancy or breast-feeding (women of child-bearing potential)
6. Not signed informed consent or non-compliance with treatment protocols

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02054078
• Other Study ID Numbers: CTSL002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xiaofei Li, Tang-Du Hospital
• Study Sponsor: Tang-Du Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tang-Du Hospital
• Verification Date: February 2014