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

Pleural Effusion, Malignant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394105
• Other study ID #: C2015-00353_Pleurodesis
• Status: Completed
• Phase: Phase 2
• Start date: July 26, 2016
• Est. completion date: June 22, 2018

Study information

• Verified date: March 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-small Cell Carcinoma
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall respose rate(ORR)	Rate of CR and PR	through study completion (2.5 years)
Primary	Complete resonse (CR) rate		through study completion (2.5 years)
Secondary	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)
Secondary	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)
Secondary	Adverse Event	Based on National Cancer Institute Common Toxicity Criteria	through study completion (2.5 years)