Pharmacogenomic Study for Individual Response to CPT-11 in Colorectal Cancer Patients (Step 2)

Pharmacogenomic Study for Individual Response to CPT-11 in Colorectal Cancer Patients (Step 2) - Pharmacogenomic Study of CPT-11 in Colorectal Cancer Patients (Step 2)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000102

Enrollment

Registered

2005-10-01

Start date

2004-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV colorectal cancer after palliative operation

Interventions

Intravenous adminstration of CPT-11 100 mg/m2 on Days 1, 8, and 15, every 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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=50 ml/min., C-reactive protein=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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactMasahiko Nishiyama

Research Institute for Radiation Biology and Medicine, Hiroshima University Department of Translational Cancer Research

yamacho@hiroshima-u.ac.jp082-257-5839

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026