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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Stage IV colorectal cancer after palliative operation | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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.
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Name of secondary funder(s) | None |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 | ||||||
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Interim results have been published. (ASCO2006 Abst.#2060; ESMO2006 Abst.# 841P) |
Management information | |||||||
Registered date |
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Last modified on |
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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 |