Unique ID issued by UMIN | C000000101 |
---|---|
Receipt number | R000000149 |
Scientific Title | A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2) |
Date of disclosure of the study information | 2005/10/01 |
Last modified on | 2008/09/01 13:45:00 |
A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2)
A phase II study of paclitaxel weekly administration for metastatic gastric cancer
A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2)
A phase II study of paclitaxel weekly administration for metastatic gastric cancer
Japan |
Fluoropyrimidine failure metastatic gastric cancer
Gastroenterology |
Malignancy
YES
To evaluate the efficacy and safety of weekly 90 mg/m2 paclitaxel administration for fluoropyrimidine-resistant metastatic gastric cancer patients, and identify the possible biomarkers
Safety,Efficacy
Confirmatory
Explanatory
Phase II
1)Tumor response rate
2)Genotype-phenotype association (CYP3A4 and CYP2C8 vs toxicity), and expression-phenotype association (MDR1 and TUBB vs tumor response)
1)Adverse events,
2)Progression free-survival (PFS)
3)Overall survival (OS)
4)Genotype-phenotype association (CYP3A4 and CYP2C8 vs PK parameter)
5) Gene expression-phenotype association
(MDR1 and TUBB vs PK parameter)
6) Possible pharmacogenomic factors other than CYP3A4, CYP2C8, MDR1, and TUBB
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intravenous administration of paclitaxel 90 mg/m2 on Days 1, 8, and 15, every 4 weeks
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(1)With pathologically proven gastric cancer
(2)With advanced gastric cancer resistant to fluoropyrimidines (up to 1 prior regimen other than fluoropyrimidines-based therapy)
(3)With at least one measurable lesion (RECIST)
(4)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as:
white blood cell count>=4000 mm3, neutrophil count>=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level<=1.5 mg/dl, BUN<=25 mg/dl, serum creatinine level<=1.5 mg/dl, creatinine clearance>=50 ml/min., C-reactive protein <=1.0 mg/dl, normal ECG
(5)ECOG performance status<=2
(6)Prior chemotherapy was completed>=28 days prior to entry
(7)Life expectancy estimated>=12 weeks
(8)Age 20-75 years
(9)With collected tissue samples for pharmacogenomic analysis
(10)With written informed consent
(1)With other serious disease:
Ischemic heart disease, arrhythmia, Myocardiac infarction occurred within 6 month,Liver cirrhosis, Hemorrhage/bleeding>=grade3(NCI-CTC),Symptomatic psychological disease, Uncontrollable diabetes, Obstructive bowel disease
(2)Active secondary cancer
(3)A past history of drug allergy
(4)A past history of allergic reaction to polyoxy-ethilen oil
(5)Prior chemotherapy including a taxane
(6)Peripheral neuropathy>=grade 2 in prior chemotherapy
(7)Pregnancy or breast feeding
(8)Ineligible decision by principal investigator
(9)Active hepatitis or syphilis
50
1st name | |
Middle name | |
Last name | Masahiko Nishiyama |
Research Institute for Radiation Biology and Medicine, Hiroshima University
Department of Translational Cancer Research
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
082-257-5839
1st name | |
Middle name | |
Last name | Masahiko Nishiyama |
Research Institute for Radiation Biology and Medicine, Hiroshima University
Department of Translational Cancer Research
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
082-257-5839
http://www.hictdo.or.jp/tiken.html
yamacho@hiroshima-u.ac.jp
Hiroshima Cancer Therapy Development Organization (HiCTDO)
Hiroshima Cancer Therapy Development Organization (HiCTDO)
Self funding
Japan
Hiroshima Univ., Iwate Med. Univ.,Toyosu Hosp., Showa Univ., Kanagawa Cancer Ctr Hosp., Grad. Sch. Med., Hokkaido Univ., Kawakita Hosp., Grad. Sch. Med., Kobe Univ.
None
YES
HiCTDO protocol #1
Hiroshima Cancer Therapy Development Organization (HiCTDO)
2005 | Year | 10 | Month | 01 | Day |
http://www.hictdo.or.jp/tiken.html
Unpublished
Paper is being prepared (Sep. 1/2008)
Completed
2004 | Year | 04 | Month | 01 | Day |
2004 | Year | 04 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2008 | Year | 06 | Month | 01 | Day |
Step 1 (phase I) has been completed.
(http://www.asco.org/ac/1,1003_12-
002636-00_18-0026-00_19-003091, 00.asp)
2005 | Year | 09 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000149
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