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Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma (DPTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827070
Recruitment Status : Unknown
Verified September 2019 by Center Trials & Treatment Europe.
Recruitment status was:  Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Center Trials & Treatment
Information provided by (Responsible Party):
Center Trials & Treatment Europe

Study Description
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Brief Summary:

In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is formed.

Currently, the most common and effective method of obliteration of the pleural cavity is pleurodesis with talcum powder.

Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering of the lungs and chest wall. As a result, the liquid ceases to accumulate.

The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the pleural cavity, but also reduces tumor and metastatic processes.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Afatinib Drug: Talcum powder Phase 1

Detailed Description:

The proposed procedure for dry pleurodesis consists of one stage.

Talc is introduced into the pleural cavity in several ways:

  • Drainage - a tube is inserted into the pleural cavity through a puncture in the chest, and then a pasty talcum is delivered into the cavity, which spreads through the cavity during the change of the patient's body position.
  • Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural cavity of the patient, which allows him to evenly distribute and significantly increases the effectiveness of the procedure.

In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and afatinib is subjected to the procedure of pharmaceutical mixing.

The operation is well tolerated by participants and lasts no more than 30 minutes. The effectiveness of the method is 90%.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Masking Description: None (Open Label)
Primary Purpose: Treatment
Official Title: New Method of Treatment for Thoracoscopy or Bronchoscopy by Suspension of Fine Powder of Talcum and Afatinib is Used in Patients With Positive Mutation of EGFR in Non-Small Cell Lung Carcinoma (NSCLC)
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : November 9, 2019
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Talcum powder & Afatinib
Talcum powder 4 g + Afatinib 0,4 g. Is entered once
 Drug: Afatinib
Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%
Other Name: BIBW2992

Drug: Talcum powder
Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (<5 μm) - only 11%
Other Name: Talc


Outcome Measures
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Primary Outcome Measures :
  1. The effectiveness of the procedure of dry pleurodesis through a thoracoscope [ Time Frame: up to 90 days ]

    Evaluation of the effectiveness of the dry pleurodesis procedure in combination with talc and afatinib with the introduction of a powder suspension through a thoracoscope.

    The assessment is performed by CT (computed tomography) of each participant twice: 30 days from the day of the procedure and 90 days later.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-small cell lung cancer with positive mutation of EGFR verified
  • Malignant pleural effusion
  • Recurrent pleural effusion
  • Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography.
  • Karnofsky index > 50
  • Agreed to participate in the study and sign an Informed Consent

Exclusion Criteria:

  • Radiotherapy not earlier than 3 months before the pleurodesis procedure
  • Previous surgeries on the same hemitorace
  • Thrombocytopenia or coagulation disorders
  • Trapped lung syndrome
  • Patients with estimated life expectancy < 4-8 weeks
  • Pleural or active systemic infection
Contacts and Locations
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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): NCT03827070


Locations
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Georgia
Central Contact
Tbilisi, Georgia, 0008
Sponsors and Collaborators
Center Trials & Treatment Europe
Center Trials & Treatment
More Information
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Responsible Party: Center Trials & Treatment Europe
ClinicalTrials.gov Identifier: NCT03827070    
Other Study ID Numbers: 9TJJ425H1D
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center Trials & Treatment Europe:
Afatinib
Talcum powder
Thoracoscopy
Pleurodesis
BIBW2992
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action