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

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ClinicalTrials.gov Identifier: NCT03394105
Recruitment Status : Completed
First Posted : January 9, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Chang-Min Choi, 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.

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Non-small Cell Carcinoma Drug: intrapleural docetaxel administration Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Effect of Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
Actual Study Start Date : July 26, 2016
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : June 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: intrapleural docetaxel administration
Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant effusion with lung cancer.
Drug: intrapleural docetaxel administration
intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer
Other Name: Pleurodesis_docetaxel




Primary Outcome Measures :
  1. Overall respose rate(ORR) [ Time Frame: through study completion (2.5 years) ]
    Rate of CR and PR

  2. Complete resonse (CR) rate [ Time Frame: through study completion (2.5 years) ]

Secondary Outcome Measures :
  1. Time to progression(TTP) [ Time Frame: through study completion (2.5 years) ]
    time from the date of the start of treatment until the disease progression or death.

  2. Overall survival(OS) [ Time Frame: through study completion (2.5 years) ]
    time fromthe date of the start of treatment to death or the date of last follow-up

  3. Adverse Event [ Time Frame: through study completion (2.5 years) ]
    Based on National Cancer Institute Common Toxicity Criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394105


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: CHANG-MIN CHOI, MD, PhD Asan Medical Center

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Responsible Party: Chang-Min Choi, associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03394105     History of Changes
Other Study ID Numbers: C2015-00353_Pleurodesis
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang-Min Choi, Asan Medical Center:
Pleurodesis

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action