Unique ID issued by UMIN | UMIN000010739 |
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Receipt number | R000012544 |
Scientific Title | Phase II trial of amrubicin treatment as palliative-intended chemotherapy for previously treated malignant pleural mesothelioma |
Date of disclosure of the study information | 2013/05/16 |
Last modified on | 2019/03/22 11:32:27 |
Phase II trial of amrubicin treatment as palliative-intended chemotherapy for previously treated malignant pleural mesothelioma
Phase II study of amrubicin for previously treated malignant pleural mesothelioma
Phase II trial of amrubicin treatment as palliative-intended chemotherapy for previously treated malignant pleural mesothelioma
Phase II study of amrubicin for previously treated malignant pleural mesothelioma
Japan |
malignant pleural mesothelioma
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To investigate for efficacy and toxicities of amrubicin monotherapy for previously treated malignant pleural mesothelioma
Safety,Efficacy
response rate
progression-free survival, overall survival, toxicities, number of cycles
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
amrubicin 35mg/m^2 (day 1-3) every 3-weeks until tumor progression and unacceptable toxicities
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Definitively diagnosed with having previously untreated advanced non-small cell lung cancer by the specimens histologically or cytologically.
2) Age of more than 70 years-old
3) With adequate organ function of bone marrow reserve, liver, and kidney.
(1) PS 0-1
(2) neutrophil count => 1,500/mm^3
(3) platelet => 100,000/mm^3
(4) hemoglobin => 9.0g/dL
(5) AST/ALT < 2.5 times less than ULN
(6) T.Bil <= 1.5mg/dL
(7) serum creatinine <= 1.5mg/dL
(8) ECG: without clinically problematic abnorbomalities
(9) Peripheral neuropathy <= Grade 1
(10) SpO2 (room air) more than 92%
4) With the status of below previous treatment at the time of beginning of chemotherapy.
(1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation
(2) Surgical procedure, including pleurodesis or pleural drainage
* more than 8 weeks with lobectomy
* more than 4 weeks without lobectomy, including exploratory thoracotomy
* more than 2 weeks after completing procedure (pleurodesis or pleural drainage)
5) With expected prognosis more than 12 weeks
6) With written informed consent
1) The age of less than 70 years-old
2) Previously treated with chemotherapy
3) With uncontrolled brain metastasis
4) With clinically active infection
5) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes)
6) With uncontrolled pleural effusion
7) With active other organ cancer
8) With the history of severe drug allergy
9) With the history of hypersensivity for paclitaxel, albumin-containing agents
10) With the history of hypersensitivity for platinum agents
11) With uncontrolled digestive ulcer
12) Any patients judged by the investigator to be unfit to participate in the study
26
1st name | Yukio |
Middle name | |
Last name | Hosomi |
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Department of Thoracic Oncology and Respiratory Medicine
113-8677
22, Honkomagome, Bunkyo Tokyo
03-3823-2101
yhosomi@cick.jp
1st name | Yusuke |
Middle name | |
Last name | Okuma |
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Department of Thoracic Oncology and Respiratory Medicine
113-8677
3-18-22, Honkomagome, Bunkyo Tokyo
03-3823-2101
y-okuma@cick.jp
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
Self funding
Ethics committee of Tokyo Metropolitan Komagome Hospital
Honkomagome 3-18-22, Bunkyo, Tokyo
03-3823-2101
rinri@cick.jp
NO
2013 | Year | 05 | Month | 16 | Day |
Unpublished
6
Terminated
2013 | Year | 06 | Month | 25 | Day |
2013 | Year | 06 | Month | 25 | Day |
2013 | Year | 06 | Month | 25 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2013 | Year | 05 | Month | 16 | Day |
2019 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012544
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