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

Asan Medical Center

Status and phase

Completed

Phase 2

Conditions

Pleural Effusion, Malignant

Non-small Cell Carcinoma

Treatments

Drug: intrapleural docetaxel administration

Study type

Interventional

Funder types

Other

Identifiers

NCT03394105

C2015-00353_Pleurodesis

Details and patient eligibility

About

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

Full 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.

Enrollment

4 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No 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