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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill
    • Raleigh, North Carolina, United States
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment	Drug: Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment safety	Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)	12 weeks
Technical success	Device deployment and infusion success	procedure day

Secondary Outcome Measures

Outcome Measure	Time Frame
Airway patency improvements	6 weeks
Quality of Life	12 weeks

Collaborators and Investigators

• Sponsor: Mercator MedSystems, Inc.
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Yarmus L, Mallow C, Akulian J, Lin CT, Ettinger D, Hales R, Voong KR, Lee H, Feller-Kopman D, Semaan R, Seward K, Wahidi MM. Prospective Multicentered Safety and Feasibility Pilot for Endobronchial Intratumoral Chemotherapy. Chest. 2019 Sep;156(3):562-570. doi: 10.1016/j.chest.2019.02.006. Epub 2019 Feb 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (ESTIMATE): February 19, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: TSP0147; 5R42CA141907-03 (NIH)