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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000102
Receipt No. R000000150
Scientific Title Pharmacogenomic Study for Individual Response to CPT-11 in Colorectal Cancer Patients (Step 2)
Date of disclosure of the study information 2005/10/01
Last modified on 2008/09/01

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Basic information
Public title Pharmacogenomic Study for Individual Response to CPT-11 in Colorectal Cancer Patients (Step 2)
Acronym Pharmacogenomic Study of CPT-11 in Colorectal Cancer Patients (Step 2)
Scientific Title Pharmacogenomic Study for Individual Response to CPT-11 in Colorectal Cancer Patients (Step 2)
Scientific Title:Acronym Pharmacogenomic Study of CPT-11 in Colorectal Cancer Patients (Step 2)
Region
Japan

Condition
Condition Stage IV colorectal cancer after palliative operation
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of weekly 100 mg/m2 CPT-11 administration as the first-line adjuvant chemotherapy for Stage IV colorectal cancer patients, and identify the potent biomarkers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 1)Tumor response rate
2)Genotype-phenotype association (CYP3A4,CES1,2, UGT1A1, ABCG2, ABCB1, and ABCC1,2 vs toxicity), mutation -phenotype association (TOP1A, ABCG2 vs tumor response), and expression-phenotype association (TOP1A, ABCG2 vs tumor response)
Key secondary outcomes 1)Adverse events,
2)Progression free-survival (PFS)
3)Overall survival (OS)
4)Genotype-phenotype association (CYP3A4,CES1,2, UGT1A1, ABCG2, ABCB1, and ABCC1,2 vs PK parameter)
Gene expression-phenotype association
(TOP1A, ABCG2 vs PK parameter)
5)Possible biomarkers other than the above 9 genes
6)Microsatellite instability (MSI)- phenotyppe association
(BAT26, D2S136, D3S1067, TP53, and D18S51 vs tumor response)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous adminstration of CPT-11 100 mg/m2 on Days 1, 8, and 15, every 4 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria (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:
white blood cell count 4000-12,000 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)No prior therapy other than the palliative operation
(7)Palliative operation was completed>=21 days prior to entry
(8)Life expectancy estimated>=12 weeks
(9)Age 20-75 years
(10)With collected tissue samples for pharmacogenomic analysis
(11)With written informed consent
Key exclusion criteria (1)Other serious accompanied diseases
(2)Symptomatic infectious disease
(3)Watery diarrhea
(4)Ileus, Obstructive bowel disease
(5)Interstitial pneumonia, pulmonary fibrosis
(6)Symptomatic ascites or pleural effusion
(7)Symptomatic jaundice
(8)Ischemic heart disease or arrhythmia required medical care
(9)Myocardiac infarction occurred within 6 month,
(10)Liver cirrhosis
(11)Hemorrhage/bleeding>=grade 3 (NCI-CTC)
(12)Symptomatic psychological disease
(13)Uncontrollable diabetes
(14)Serious surgery-related complication
(15)Active secondary cancer
(16)A past history of drug allergy
(17)Pregnancy or breast feeding
(18)Active hepatitis or syphilis
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Nishiyama
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name Department of Translational Cancer Research
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5839
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Nishiyama
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name Department of Translational Cancer Research
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5839
Homepage URL http://www.hictdo.or.jp/tiken.html
Email yamacho@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima Cancer Therapy Development Organization (HiCTDO)
Institute
Department

Funding Source
Organization Hiroshima Cancer Therapy Development Organization (HiCTDO)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Osaka Med. Ctr. Cancer and Cardiovasc. Dis., Sakai City Hosp., Osaka Seamen's Insurance Hosp., Kobe Univ., Hokkaido Univ., Suita Municipal Hosp., Aomori Municipal Hosp., Hiroshima Univ.
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 HiCTDO protocol #3
Org. issuing International ID_1 Hiroshima Cancer Therapy Development Organization (HiCTDO)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 10 Month 01 Day

Related information
URL releasing protocol http://www.hictdo.or.jp/tiken.html
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Paper is being prepared (Sep.1/2008)
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 12 Month 01 Day
Date trial data considered complete
2007 Year 12 Month 01 Day
Date analysis concluded
2008 Year 06 Month 01 Day

Other
Other related information Interim results have been published. (ASCO2006 Abst.#2060; ESMO2006 Abst.# 841P)

Management information
Registered date
2005 Year 09 Month 01 Day
Last modified on
2008 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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