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

UMIN ID: C000000102

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage IV colorectal cancer after palliative operation
• Date of first enrollment: 2004/04/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravenous adminstration of CPT-11 100 mg/m2 on Days 1, 8, and 15, every 4 weeks

Outcome(s)

• Primary Outcome: 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 Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Hiroshima Cancer Therapy Development Organization (HiCTDO)
• Secondary 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.
• Source(s) of Monetary Support: Hiroshima Cancer Therapy Development Organization (HiCTDO),None
• Secondary ID(s): HiCTDO protocol #3