Patients with unresectable or metastatic colon cancer registant to fluorouracil treatment
Conditions
Interventions
DAY 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ....... | 5-FU 400mg/m2 iv Rapid
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) colon cancer proven histologically 2) unresectable or metastatic colon cancer 3) with prior chemotherapy of fluoropyrimidine O the last prior therapy before more than 4 weeks of registration O without L-OHP therapy O For patients with postoperative adjuvant chemotherapy, progression is observed on x-ray examination or tumor marker examination within 26 weeks of adjuvant chemotheray. 4) with measurable metastatic lesions 5) age: =>20 and 75=> 6) Performance Status: 0-1 (ECOG criteria) 7) more than 12 weeks of expected survival period 8) sufficient function of important organs O WBC: >= 4,000 and =< 12,000/mm3 O Platelet: >= 100,000/mm3 O sGOT,sGPT: 2.5 times of normal range in each institute O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= upper limit of each institute O ECG: normal range 9) written informed consent
Exclusion criteria
Exclusion criteria: "1) Cavity fluid which needs drainage 2) with active double cancer except ca. in situ 3) with peripheral nerve disorder 4) with infectious disease which needs treatment 5) under watery diarrhea 6) with mental disorder which disturbs registration to this study 7) patients who receive steroids treatment 8) Cardiac failure, liver dysfunction, or renal dysfunction which disturb Registration to this study 9) pregnant women or women who like to be pregnant 10) history of severe allergy against drug 11) doctor's dicision not to be registered to this study"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate(RECIST), Duration of response | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Feasibility Adverse Events | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Sakai City Hospital Director
Outcome results
None listed