advanced/recurrent colorectal cancer
Conditions
Interventions
CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 3 consecutive weeks every 5 weeks.
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathological confirmation of Adenocarcinoma 2) Patients with confirmed target lesion 3) Patient with/without prior chemotherapy. 4) Age of 20~75 5) ECOG performance status of 0 to 1 6) Expected more than 3 months survival 7) Sufficient function of important organs 1.WBC:4,000~12,000 /mm3 2.Neu : >= 2,000 /mm3 3.Platelet : >= 100,000 /mm3 4.hemoglobin : >= 9.0 g/dL 5.AST, ALT : < ULNx2.5 IU/L 6.Sr.bil : < 1.5 mg/dL 7.Serum creati : <= ULN 8.Ccr : >= 50 ml/min 8) With written informed consent 9) Sufficient oral intake
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumoni, fibroid lung 2) Massive pleural or abdominal effusion 3) Patients with active synchronous or metachronous malignancy other than carcinoma in situ 4) Infection, intestinal paralysis / enterostasis 5) Watery stools or diarrhea 6) Uncontrolled diabetes mellitus 7) Severe complications 8) Metastasis to CNS 9) Pregnant or lactating woman 10) History of the severe hypersensitivity 11) Systemic administration of corticosteroids 12) Other patients who are unfit for the study as determined by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, frequency and grade of adverse event | — |
Countries
Japan
Outcome results
None listed