Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer
Phase 2
- Conditions
- Chemotherapy-na&iumlve stage IV colorectal cancer after palliative operation
- Registration Number
- JPRN-C000000424
- Lead Sponsor
- Development Organization for Frontier Medical Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate(best tumor shrinkage(rate))
- Secondary Outcome Measures
Name Time Method 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