Chemotherapy-na&
Conditions
Interventions
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
Sponsors
Development Organization for Frontier Medical Therapeutics
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.
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: Leucocyte count >=4000 mm3, neutrophil count >=2000 mm3, platelet count >=100,000 mm3, haemoglobin >=9.0 g/dl, AST and ALT ==60 ml/min., BUN level =<25 mg/dl and normal ECG (5)ECOG performance status =<2 (6)No prior therapy other than the palliative operation (7)Palliative operation was completed<= one month prior to chemotherapy (8)With collected tissue samples for pharmacogenomic analysis (9)Life expectancy estimated >=12 weeks (10)With written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate(best tumor shrinkage(rate)) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasahiko Nishiyama
Research Institute for Radiation Biology and Medicine,Hiroshima University Department of Translational Cancer Research
Outcome results
None listed