Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer

Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer

In this trial, the effect of intrapleural docetaxel administration using medical pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion, Malignant; Non-small Cell Carcinoma
• Intervention / Treatment: Drug: intrapleural docetaxel administration

Detailed Description

This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS approval date.

Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer. Response evaluation will be done until confiramtion of disease progression.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 20, and NSCLC patients with malignant pleural effusion and related symptoms
• ECOG ≤ 2
• Blood test ANC≥ 1500/mm3, Hb ≥ 8.0g/dl, platelet count ≥ 100000/mm3 Serum creatinine ≤ 1.8mg/dl, Total bilirubin within normal limits, Transaminases ≤ 1.5 x UNL, Alkaline phosphatase ≤ 2.5 X UNL BUN ≤ 25mg/dl, Creatinine clearance ≥ 50ml/min
• Negative serum or urine pregnancy test for women for childbearing age
• Patients who provide written informed consent for the study

Exclusion Criteria:

• Age < 20
• Patients who were previously perfomed pleurodesis
• Patients who were previously treated with thoracic radiosurgery
• Patinet with bilateral pleural effusion
• Age ≥ 80yrs
• Patients with histories of hypersensitivity to Docetaxel
• Patients with cardiovascular, respiratory, hepatic, renal, gastrointestinal, neunological disease, asthma, MI, stroke, arrhythmia, uncontrolled hypertionsion, etc. that would effect absorption, distribution, and metabolism of IP or be risk factors during IP administrion.
• Patients who could not understand the study procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intrapleural docetaxel administration; Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.	Drug: intrapleural docetaxel administration; intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer; Other Names: Pleurodesis_docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall respose rate(ORR)	Rate of CR and PR	through study completion (2.5 years)
Complete resonse (CR) rate		through study completion (2.5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression(TTP)	time from the date of the start of treatment until the disease progression or death.	through study completion (2.5 years)
Overall survival(OS)	time fromthe date of the start of treatment to death or the date of last follow-up	through study completion (2.5 years)
Adverse Event	Based on National Cancer Institute Common Toxicity Criteria	through study completion (2.5 years)

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: CHANG-MIN CHOI, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2016
• Primary Completion (Actual): June 22, 2018
• Study Completion (Actual): June 22, 2018

Study Registration Dates

• First Submitted: October 9, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Pleurodesis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: C2015-00353_Pleurodesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No