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

Primary Purpose

Pleural Effusion, Malignant, Non-small Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

intrapleural docetaxel administration

About this trial

This is an interventional treatment trial for Pleural Effusion, Malignant focused on measuring Pleurodesis

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intrapleural docetaxel administration

Arm Description

Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.

Outcomes

Primary Outcome Measures

Overall respose rate(ORR)

Rate of CR and PR

Complete resonse (CR) rate

Secondary Outcome Measures

Time to progression(TTP)

time from the date of the start of treatment until the disease progression or death.

Overall survival(OS)

time fromthe date of the start of treatment to death or the date of last follow-up

Adverse Event

Based on National Cancer Institute Common Toxicity Criteria

Full Information

NCT ID

NCT03394105

First Posted

October 9, 2017

Last Updated

March 6, 2019

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03394105

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

July 26, 2016 (Actual)

Primary Completion Date

June 22, 2018 (Actual)

Study Completion Date

June 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pleural Effusion, Malignant, Non-small Cell Carcinoma

Keywords

Pleurodesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intrapleural docetaxel administration

Arm Type

Experimental

Arm Description

Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.

Intervention Type

Drug

Intervention Name(s)

intrapleural docetaxel administration

Other Intervention Name(s)

Pleurodesis_docetaxel

Intervention Description

intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer

Primary Outcome Measure Information:

Title

Overall respose rate(ORR)

Description

Rate of CR and PR

Time Frame

through study completion (2.5 years)

Title

Complete resonse (CR) rate

Time Frame

through study completion (2.5 years)

Secondary Outcome Measure Information:

Title

Time to progression(TTP)

Description

time from the date of the start of treatment until the disease progression or death.

Time Frame

through study completion (2.5 years)

Title

Overall survival(OS)

Description

time fromthe date of the start of treatment to death or the date of last follow-up

Time Frame

through study completion (2.5 years)

Title

Adverse Event

Description

Based on National Cancer Institute Common Toxicity Criteria

Time Frame

through study completion (2.5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

CHANG-MIN CHOI, MD, PhD

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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