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

Phase 2

Completed

• Conditions: Pleural Effusion, Malignant; Non-small Cell Carcinoma
• Interventions: Drug: intrapleural docetaxel administration

• Registration Number: NCT03394105
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2016-07-26
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Primary Completion: 2018-06-22
• Study Completion: 2018-06-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intrapleural docetaxel administration	intrapleural docetaxel administration	Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.

Primary Outcome Measures

Name	Time	Method
Overall respose rate(ORR)	through study completion (2.5 years)	Rate of CR and PR
Complete resonse (CR) rate	through study completion (2.5 years)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of