Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer

UMIN ID: C000000424

Registered date:03/06/2006

Basic Information

• Health condition(s) or Problem(s) studied: Chemotherapy-naïve stage IV colorectal cancer after palliative operation
• Date of first enrollment: 2006/06/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravenous administration of l-Leucovorin 175 mg/body, Oxaliplatin 85 mg/m2 as a 2-hour infusion followed by bolus 5-FU 400 mg/m2 and 46hr infusion 5-FU 2,400 mg/m2 every two weeks

Outcome(s)

• Primary Outcome: Response rate(best tumor shrinkage(rate))
• Secondary Outcome: 1.Overall response duration, Complete response duration, Stable duration 2.Progression free survival(PFS) 3.Time to treatment failure(TTF) 4.Overall survival(OS), Median survival time(MST), 1-year survival,2-year survival 5.Adverse events 6.Possible biomarkers a)Association of genotype of DPYD, TYMS, ERCC1, ERCC2, XRCC1, GSTP1, EGFR, VEGF and TNFRSF1B and expression of DPYD, TYMS, ECGF1 and ERCC1 with phenotype b)Identification of possible biomarker genes other than DPYD, TYMS, ECGF1, ERCC1, ERCC2, XRCC1, GSTP1, EGFR, VEGF and TNFRSF1B c)Association of platinum concentration in plasma and ultrafiltrate with neurotoxicity and allergic reaction

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1)Symptomatic infectious disease (2)Watery diarrhea (3)Ileus, obstructive bowel disease (4)Interstitial pneumonia, pulmonary fibrosis (5)Symptomatic malignant ascites, pleural or pericardial effusion (6)Peripheral neuropathy >= grade 2 (DEB-NTC) (7)Ischemic heart disease or arrhythmia required medical care (8)Myocardiac infarction occurred within 6 months (9)Liver cirrhosis (10)Hemorrhage, GI-Select >= grade 3 (NCI-CTC) (11)Symptomatic psychological disease (12)Uncontrollable diabetes (13)Active secondary malignancies (14)A past history of severe drug allergy (15)Concomitant therapy with phenytoin or warfarin potassium (16)Pregnancy or breast feeding (17)Other severe comorbid condition

Related Information

• Primary Sponsor: Development Organization for Frontier Medical Therapeutics
• Secondary Sponsor: Kitazato Univ.,Saitama Med.Sch., Kansai Rosai Hosp.,Sakai Mun.Hosp.,Suita Mun. Hosp.,Osaka Seamen's Insur. Hosp.,Osaka Med.Ctr.Cancer and Cardiovasc. Dis.,Okayama Univ.,Kobe Univ.,Hiroshima Univ.
• Source(s) of Monetary Support: Development Organization for Frontier Medical Therapeutics,none
• Secondary ID(s): HiCTDO protocol #7