advanced/recurrent colorectal cancer
Conditions
Interventions
It takes 2 weeks for one course and that is to be repeated. Dose schedule for one course CPT-11 150mg/ m2/day Day 1 5-FU 500 mg/m2/day Day 1 l-LV 15 mg/m2/day Day 1 UFT 300 mg/
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) diagnosed as colon cancer pathologically 2)with measurable lesions 3)without prior chemotherapy 4)without prior radiation therapy 5)20 years old <= => 75 years old 6)Performance status: 0 &#8211; 1 (ECOG) 7)Expected survival more than 12 weeks 8)Within labo. data level written, subsequently WBC >= 4,000/mm3 and <= 12,000/mm3 Neutrocyte >= 2,000/mm3 Platelet >= 100,000/mm3 sGOT, sGPT <upper limit of each institute x 2.5 sBil <= 2.0mg/dl creatinin <= upper limit of each institute Normal ECG 9)Informed Consents with written form 10) Patients who can take orally
Exclusion criteria
Exclusion criteria: 1)interstitial pneumonitis or pulmonary fibrosis 2)with cavity fluid to be treated 3)with present active double cancer or D.B. diagnosed less than 5 years before, excluding cured cancer in situ or skin cancer 4)ileus 5)watery diarrhea 6)D.M. which needs insulin or uncontrolled D.M. 7)With other diseases which influence to the study (heart diseases, liver dysfunction, renal failure) 8)brain metastasis with some symptoms 9)pregnant women or suspected women 10)receiving atazanavir sulfate 11)Receiving steroids treatment 12)With experience of drug anaphylaxis shock 13)Doctor stop due to miscellaneous factors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, overall survival,progression-free survival,time to treatment failure. | — |
Countries
Japan
Outcome results
None listed