Unique ID issued by UMIN | C000000424 |
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Receipt number | R000000489 |
Scientific Title | Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer |
Date of disclosure of the study information | 2006/06/03 |
Last modified on | 2008/05/29 09:24:15 |
Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer
Pharmacogenomic study of modified FOLFOX6 in colorectal cancer
Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer
Pharmacogenomic study of modified FOLFOX6 in colorectal cancer
Japan |
Chemotherapy-naïve stage IV colorectal cancer after palliative operation
Gastrointestinal surgery |
Malignancy
YES
To evaluate the efficacy and safety of modified FOLFOX6 (5-FU/l-LV+Oxaliplatin)therapy as the first-line adjuvant chemotherapy for stage IV colorectal cancer patients, and identify the potent biomarkers
Safety,Efficacy
Confirmatory
Explanatory
Phase II
Response rate(best tumor shrinkage(rate))
1.Overall response duration, Complete response duration, Stable duration
2.Progression free survival(PFS)
3.Time to treatment failure(TTF)
4.Overall survival(OS), Median survival time(MST), 1-year survival,2-year survival
5.Adverse events
6.Possible biomarkers
a)Association of genotype of DPYD, TYMS, ERCC1, ERCC2, XRCC1, GSTP1, EGFR, VEGF and TNFRSF1B and expression of DPYD, TYMS, ECGF1 and ERCC1 with phenotype
b)Identification of possible biomarker genes other than DPYD, TYMS, ECGF1, ERCC1, ERCC2, XRCC1, GSTP1, EGFR, VEGF and TNFRSF1B
c)Association of platinum concentration in plasma and ultrafiltrate with neurotoxicity and allergic reaction
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intravenous administration of l-Leucovorin 175 mg/body, Oxaliplatin 85 mg/m2 as a 2-hour infusion followed by bolus 5-FU 400 mg/m2 and 46hr infusion 5-FU 2,400 mg/m2 every two weeks
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(1)With pathologically proven colorectal cancer
(2)With Stage IV colorectal cancer after palliative operation
(3)With at least one measurable lesion (RECIST)
(4)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as:
Leucocyte count >=4000 mm3, neutrophil count >=2000 mm3, platelet count >=100,000 mm3, haemoglobin >=9.0 g/dl, AST and ALT ==60 ml/min., BUN level =<25 mg/dl and normal ECG
(5)ECOG performance status =<2
(6)No prior therapy other than the palliative operation
(7)Palliative operation was completed<= one month prior to chemotherapy
(8)With collected tissue samples for pharmacogenomic analysis
(9)Life expectancy estimated >=12 weeks
(10)With written informed consent
(1)Symptomatic infectious disease
(2)Watery diarrhea
(3)Ileus, obstructive bowel disease
(4)Interstitial pneumonia, pulmonary fibrosis
(5)Symptomatic malignant ascites, pleural or pericardial effusion
(6)Peripheral neuropathy >= grade 2 (DEB-NTC)
(7)Ischemic heart disease or arrhythmia required medical care
(8)Myocardiac infarction occurred within 6 months
(9)Liver cirrhosis
(10)Hemorrhage, GI-Select >= grade 3 (NCI-CTC)
(11)Symptomatic psychological disease
(12)Uncontrollable diabetes
(13)Active secondary malignancies
(14)A past history of severe drug allergy
(15)Concomitant therapy with phenytoin or warfarin potassium
(16)Pregnancy or breast feeding
(17)Other severe comorbid condition
60
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 734-8553, 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 734-8553, Japan
082-257-5839
http://www.hictdo.or.jp/tiken.html
yamacho@hiroshima-u.ac.jp
Development Organization for Frontier Medical Therapeutics
Development Organization for Frontier Medical Therapeutics
Self funding
Japan
Kitazato Univ.,Saitama Med.Sch., Kansai Rosai Hosp.,Sakai Mun.Hosp.,Suita Mun. Hosp.,Osaka Seamen's Insur. Hosp.,Osaka Med.Ctr.Cancer and Cardiovasc. Dis.,Okayama Univ.,Kobe Univ.,Hiroshima Univ.
none
YES
HiCTDO protocol #7
Development Organization for Frontier Medical Therapeutics
2006 | Year | 06 | Month | 03 | Day |
http://www.hictdo.or.jp/tiken.html
Unpublished
2006 | Year | 06 | Month | 01 | Day |
2006 | Year | 06 | Month | 01 | Day |
2010 | Year | 05 | Month | 01 | Day |
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2010 | Year | 07 | Month | 01 | Day |
2006 | Year | 05 | Month | 29 | Day |
2008 | Year | 05 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000489
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