Unique ID issued by UMIN | UMIN000009067 |
---|---|
Receipt number | R000010642 |
Scientific Title | Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer |
Date of disclosure of the study information | 2012/10/16 |
Last modified on | 2016/06/20 08:43:10 |
Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancer
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To evaluate tolerared dose and recommended dose of Gemcitabine and nab-Paclitaxel combination chemotherapy for metastatic breast cancer
Safety
Phase I
To determinate maximum tolerated dose and recommended dose
To determinate pharmacokinetics of nab-Paclitaxel and to validate feasibility
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gemcitabine:1250mg/m2 day1,8
nab-Paclitaxel:180mg/m2-260mg/m2 day1
every 3 weeks
20 | years-old | <= |
75 | years-old | >= |
Female
1)Histrogical confirmed primary breast cancer
2)Clinically confirmed metastatic breast cancer
3)HER2 negative confirmed by IHC or FISH
4)Age are 20-75 years old
5)None primary treatment with Paclitaxel and Gemcitabine
*More than 6 months from Neo-adjuvant or adjuvant chemotherapy by paclitaxel or Gemcitabine
6)Required baseline primary treastment
More than 4 weeks from surgery
More than 2weeks from radiotherapy or endocrine therapy
7)Performance status of 0 or 1
8)Required baseline laboratory date
WBC:4000/mm3-12000/mm3
Neu:>=4000/mm3
Plt:>=100000/mm3
Hb:>=9.0g/dL
ALT and AST:<2.5 times of nomal range in institute
T-Bil:<=1.5mg/dL
Cr:<=1.5mg/dL
9)Expected survival time:more than 3 months
10)Written informed consent
1)Allergy of the Gemcitabine or nab-Paclitaxel
2)Contraindication to treatment with Gemcitabine or nab-Paclitaxel
3)With sever complications
ex.)with incontrollable diabetes,with infection,mental disorder which become problem on clinical practice
4)During pregnancy or lactation
5)With extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea
6)With active double cancer
7)With symptomatic brain cancer
8)HBs antigen is positive
9)With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease
10)With pulmonary fibrosis or pneumonitis
11)With dyspnea at rest
12)With uncontrolled pleural effusion, peritoneal effusion, pericardial effusion
13)With grade 2 or grater peripheral neuropathy
14)Patients judged by the investigator as unfit to be enrolled in the study
9
1st name | |
Middle name | |
Last name | Naruto Taira |
Okayama University Hospital
Breast and endocrical surgery
2-5-1 Shikata-machi Kita-ku Okaya-shi
086-235-7265
ntaira@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Naruto Taira |
Okayama University Hospital
Breast and endocrical surgery
2-5-1 Shikata-machi Kita-ku Okaya-shi
086-235-7265
ntaira@md.okayama-u.ac.jp
Okayama Univesity Hospital
None
Self funding
NO
2012 | Year | 10 | Month | 16 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/27316438
Completed
2012 | Year | 09 | Month | 12 | Day |
2012 | Year | 11 | Month | 01 | Day |
2014 | Year | 05 | Month | 15 | Day |
2014 | Year | 05 | Month | 27 | Day |
2014 | Year | 05 | Month | 27 | Day |
2014 | Year | 05 | Month | 27 | Day |
2012 | Year | 10 | Month | 09 | Day |
2016 | Year | 06 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010642
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |