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

Not Applicable

Completed

• Conditions: Malignant Airway Obstruction Secondary to Non-small Cell Lung Cancer
• Interventions: Drug: Paclitaxel

• Registration Number: NCT02066103
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-19
• Study Start: 2014-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-18
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Paclitaxel	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Airway patency improvements	6 weeks
Quality of Life	12 weeks

Trial Locations

Locations (3)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Duke University; 🇺🇸 Raleigh, North Carolina, United States

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States