Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Overall respose rate(ORR)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 20, and NSCLC patients with malignant pleural effusion and related symptoms
- •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
Arms & Interventions
intrapleural docetaxel administration
Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.
Intervention: intrapleural docetaxel administration (Drug)
Outcomes
Primary Outcomes
Overall respose rate(ORR)
Time Frame: through study completion (2.5 years)
Rate of CR and PR
Complete resonse (CR) rate
Time Frame: through study completion (2.5 years)
Secondary Outcomes
- Time to progression(TTP)(through study completion (2.5 years))
- Overall survival(OS)(through study completion (2.5 years))
- Adverse Event(through study completion (2.5 years))
Investigators
Chang-Min Choi
associate professor
Asan Medical Center