search
Back to results

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

Primary Purpose

Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Sponsored by
Mercator MedSystems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University
  • The University of North Carolina at Chapel Hill
  • Duke University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

Treatment safety
Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
Technical success
Device deployment and infusion success

Secondary Outcome Measures

Airway patency improvements
Quality of Life

Full Information

First Posted
February 13, 2014
Last Updated
April 18, 2018
Sponsor
Mercator MedSystems, Inc.
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02066103
Brief Title
Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
Acronym
BROADWAY
Official Title
Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mercator MedSystems, Inc.
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
Treatment safety
Description
Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
Time Frame
12 weeks
Title
Technical success
Description
Device deployment and infusion success
Time Frame
procedure day
Secondary Outcome Measure Information:
Title
Airway patency improvements
Time Frame
6 weeks
Title
Quality of Life
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Raleigh
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30776363
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs