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Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients (BROADWAY)

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. Identifier: NCT02066103
Recruitment Status : Completed
First Posted : February 19, 2014
Last Update Posted : April 20, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mercator MedSystems, Inc.

Brief Summary:

Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed.

This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.

Condition or disease Intervention/treatment Phase
Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer Drug: Paclitaxel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
Actual Study Start Date : July 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Treatment Drug: Paclitaxel

Primary Outcome Measures :
  1. Treatment safety [ Time Frame: 12 weeks ]
    Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)

  2. Technical success [ Time Frame: procedure day ]
    Device deployment and infusion success

Secondary Outcome Measures :
  1. Airway patency improvements [ Time Frame: 6 weeks ]
  2. Quality of Life [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver, and renal function
  • Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
  • Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
  • Measurable disease with obstruction into the airway
  • Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
  • Patients undergo recanalization procedure of tumor during bronchoscopy
  • Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization

Exclusion Criteria:

  • Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
  • Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
  • Uncontrolled infection
  • Presence or recent history of any systemic disorder or conditions, such as:

    • uncontrolled hypertension
    • type 1 diabetes
    • severe pulmonary hypertension
    • acute kidney injury
    • stroke (within the last 6 month)
    • myocardial infarction (within the last 3 months)
  • Individuals with neurological, mental or psychiatric disorders
  • Concurrent participation in another study involving investigational drugs or investigational medical devices
  • Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
  • Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media
  • Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion Criteria
  • Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation
  • Any intraoperative complications that per the investigator's judgment increase the risk to the patient.

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 identifier (NCT number): NCT02066103

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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Raleigh, North Carolina, United States
Sponsors and Collaborators
Mercator MedSystems, Inc.
National Cancer Institute (NCI)

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mercator MedSystems, Inc. Identifier: NCT02066103    
Other Study ID Numbers: TSP0147
5R42CA141907-03 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action