UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000102 |
|---|---|
| Receipt number | 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 13:51:31 |
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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
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
yamacho@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Cancer Therapy Development Organization (HiCTDO)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000150
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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