Unique ID issued by UMIN | UMIN000011672 |
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Receipt number | R000013649 |
Scientific Title | Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer |
Date of disclosure of the study information | 2013/09/06 |
Last modified on | 2013/09/06 18:50:59 |
Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer
Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer
Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer
Phase I/ II trial with abraxane and trastuzumab for advanced/recurrent HER2-positive gastric cancer
Japan |
gastric cancer
Gastroenterology |
Malignancy
NO
Efficacy and safety of abraxane and trastuzumab in patients with advanced/recurrent HER2-positive gastric cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
clinical benefit
sefety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of abraxane with a dose of 260 mg/m2 for days1 of 21 day course. Administration of trastuzumab every 3 weeks with a starting dose of 8 mg/kg followed by 6 mg/kg as the second and subsequent doses.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1. persons with gastric cancer which is confirmed to be invasive gastric cancer by histological or cytological examination.
2. Advanced/reccurent HER2-positive gastric cancer .
3. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
4. Patients with a performance status (ECOG) of 0, 1, or 2
5. Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan).
6. Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration.
(1)Neutrophil>=1,500/mm3
(2)Platelet>=100,000/mm3
(3)Hb>=9.0g/dL
(4)T-BIL<=2.0mg/dL
(5)AST, ALT <=100IU/L
(6)Serum creatinine <= 1.5mg/dL
7. Patients expected to survive for 6 months or more.
8. Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec).
9. Patients who provided written informed consent by themselves in principle to participate in this trial.
1. Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer.
2. Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema.
3. Patients with brain metastases treatment is required at the time of registration.
4. Patients with serious co-morbidities
(1)Uncontrolled diabates
(2)Uncontrolled hypertension
(3)Myocardial infarction within 24 weeks prior to registration, unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia requiring medication.
(4)Ischemic heart disease, arrhythmias, valvular disease requiring medication.
(5)Liver dysfunction(jaundice)
(6)Renal dysfunction
(7)Active infection or fever suspicious of infection.
(8)Other serious complications
5. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception.
6. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial
10
1st name | |
Middle name | |
Last name | Tetsuji Takayama |
The University of Tokushima graduate school
gastroenteroloy and oncology
15-18-3 Kuramoto-cho Tokushima-city Tokushima Japan
088-633-7142
takayama@md.pikara.ne.jp
1st name | |
Middle name | |
Last name | Kanako Otsuka |
The University of Tokushima graduate school
gastroenteroloy and oncology
15-18-3 Kuramoto-cho Tokushima-city Tokushima Japan
088-633-7142
falko326@hotmail.co.jp
The University of Tokushima graduate school
The University of Tokushima graduate school
Other
NO
2013 | Year | 09 | Month | 06 | Day |
Unpublished
Preinitiation
2003 | Year | 09 | Month | 06 | Day |
2013 | Year | 09 | Month | 09 | Day |
2013 | Year | 09 | Month | 06 | Day |
2013 | Year | 09 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013649
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