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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mercator MedSystems, Inc.
ClinicalTrials.gov Identifier:
NCT02066103
First received: February 13, 2014
Last updated: July 10, 2016
Last verified: July 2016
  Purpose

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 Intervention
Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer Drug: Paclitaxel

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mercator MedSystems, Inc.:

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

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


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

Enrollment: 20
Study Start Date: January 2014
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Paclitaxel

  Eligibility

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

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.
  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: NCT02066103

Locations
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)
  More Information

Responsible Party: Mercator MedSystems, Inc.
ClinicalTrials.gov Identifier: NCT02066103     History of Changes
Other Study ID Numbers: TSP0147
5R42CA141907-03 ( U.S. NIH Grant/Contract )
Study First Received: February 13, 2014
Last Updated: July 10, 2016

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Airway Obstruction
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Insufficiency
Respiration Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2017