Unique ID issued by UMIN | UMIN000004773 |
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Receipt number | R000005625 |
Scientific Title | A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer. |
Date of disclosure of the study information | 2010/12/22 |
Last modified on | 2010/12/22 09:10:07 |
A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer.
Feasibility study of Irinotecan(CPT-11) based on UGT1A1 polymorphisms for metastatic colorectal cancer.
A feasibility study of Irinotecan (CPT-11) by groups of Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphisms in patients with metastatic colorectal cancer.
Feasibility study of Irinotecan(CPT-11) based on UGT1A1 polymorphisms for metastatic colorectal cancer.
Japan |
Colorectal cancer
Gastrointestinal surgery |
Malignancy
YES
To estimate safety for bi-weekly FOLFIRI(+BV) therapy by the groups of UGT1A1 gene polymorhisms in patients with metastatic colorectal cancer
Safety
Exploratory
Pragmatic
Phase II
1)incidence of adverse events
2)frequency of severe toxicity
1)response rate
2)time to treatment failure
3)progression free survival
4)overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients receive FOLFIRI with bevacizumab fixed 5mg/kg. (Treatment will be continued unless the disease progression, unacceptable toxicity, or consent withdrawal.)
Definision of UGT1A1 polymorphisms groups: The homozygous group is patient with homozygous genotype of UGT1A1*28/*28 or UGT1A1*6/*6, with combined heterozygous genotypes of UGT1A1*28 and UGT1A1*6. The heterozygous group is patient with heterozygous genotype of either UGT1A1*28 or UGT1A1*6. The wild group is patients with no UGT1A1*28 and UGT1A1*6 mutation.
CPT-11 dosage is
wild and heterozygous:CPT-11 150mg/m2
homozygous:CPT-11 100mg/m2
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Histologically confirmed colorectal cancer
2) Metastatic colorectal cancer
3) FOLFOX(+BV) or XELOX(+BV) treatment failure
4) Testing confirmed UGT1A1*28 and UGT1A1*6 polymorphisms
5) Wash out:>=14 days for operation, and >=21 days for chemotherapy and/or radiotherapy
6) No prior irinotecan containing treatment
7) PS(ECOG):0 to 1
8) A life expectancy for at least 2 months
9) Aduquate main organ (bone marrow, heart, pulumonary, liver, renal) function
WBC 3,000-12,000/mm3,
Neutrophil >=1500/mm3
Platelet >=100,000/mm3
Hb >=8.5mg/dL
AST(GOT) <=100IU/L
ALT(GPT)<=100IU/L
T-bilirubin <=2.0mg/dL
serum creatinine <=1.50mg/dL
10) Written informed consent
1)History of serious drug allergy
2)Active concomitant malignancy
3)Prior extensively irradiation for abdominal or bowel bone marrow
4)Symptomatic brain metastasis
5)Systemic continual use of steroids
6)Active infection
7)Persistent diarrhea (watery stool)
8)Intestinal obstraction or paralytic ileus
9)Interstitial pneumonia or pulmonary fibrosis
10)Massive pleural, pericardial effusion or asites that required drainage
11)Need to treatment with atazanavir sulfate
12)maintained phenytoin or warfarin
13)Uncontrolled diabetes mellitus
14)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment
15)Psychological disease deemed to unacceptable for inclusion to the study
16)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy
17)Other concominant medical condition deemed to inadequate for inclusion to the study
120
1st name | |
Middle name | |
Last name | Mitsuo Shimada |
Institute of Health Biosciences,
The University of Tokushima Graduate School
Department of Digestive and Pediatric Surgery
18-15 Kuramotocho 3-chome, Tokushima city
088-633-7139
1st name | |
Middle name | |
Last name | Masanori Nishioka |
The University of Tokushima Graduate School
Department of Digestive and Pediatric Surgery
18-15 Kuramotocho 3-chome, Tokushima city
088-633-7139
Tokushima University
None
Self funding
NO
2010 | Year | 12 | Month | 22 | Day |
Unpublished
Open public recruiting
2008 | Year | 06 | Month | 10 | Day |
2009 | Year | 04 | Month | 01 | Day |
2012 | Year | 04 | Month | 01 | Day |
2010 | Year | 12 | Month | 22 | Day |
2010 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005625
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