Unique ID issued by UMIN | UMIN000011776 |
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Receipt number | R000013617 |
Scientific Title | A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer |
Date of disclosure of the study information | 2013/09/17 |
Last modified on | 2018/03/16 16:39:50 |
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in NSCLC
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer
A phase I/II study of weekly nab-Paclitaxel/Cisplatin in NSCLC
Japan |
Non-Small-Cell Lung Cancer
Pneumology |
Malignancy
NO
To evaluate the feasibility and efficacy of nab-paclitaxel and cisplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer.
Safety,Efficacy
Exploratory
Phase I,II
objective response rate
progression free survival, overall survival, toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Level 0; nab-paclitaxel 80mg/m2, day 1,8,15 cisplatin 60mg/m2 day 1 every 4 weeks
Level 1; nab-paclitaxel 80mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 every 4 weeks
Level 2; nab-paclitaxel 100mg/m2, day 1,8,15 cisplatin 75mg/m2 day 1 every 4 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Non-small cell lung cancer with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery
3)EGFR mutation negative, ALK rearrangement negative, other driver oncogenes negative
4)Age: 20- years old
5)ECOG PS 0-1
6)With measurable lesion
7)Adequate organ function
8)Written informed consent
1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of severe drug allergy
3)EGFR mutation positive, ALK rearrangement positive, other driver oncogenes positive
4)History of serious disease condition
5)Symptomatic brain metastasis
6)History of active double cancer
7)History of pregnancy or lactation
8)History of active psychological disease
35
1st name | |
Middle name | |
Last name | Miyako Satouchi |
Hyogo Cancer Center
Department of Thoracic Oncology
13-70, Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
078-929-1151
satouchi@hp.pref.hyogo.jp
1st name | |
Middle name | |
Last name | Yoshihiro Hattori |
Hyogo Cancer Center
Department of Thoracic Oncology
13-70, Kitaoji-cho, Akashi, Hyogo 673-8558, Japan
078-929-1151
hattori@hp.pref.hyogo.jp
Hyogo Cancer Center
None
Self funding
NO
2013 | Year | 09 | Month | 17 | Day |
Unpublished
Completed
2013 | Year | 08 | Month | 30 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 16 | Day |
2018 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013617
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