Meatastatic colorectal cancer
Conditions
Interventions
On Day 1, 8, 15, CPT-11 100 mg/m2 l-LV 250 mg/m2 administered simultaneously 5-FU 500 mg/m2 administered subsequently ** It takes 28 days for the one course. ** More than two courses are re
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) advanced or recurrent colon cancer with metastatic lesions 2) colon cancer proven by cytologic and/or histologic examination 3) with measurable lesions which are larger than 2 cm by CT sliced 10 mm or larger than 1cm by CT sliced 5 mm. 4) without any prior chemotherapy, or with prior CPT-11 therapy after 4 Weeks of last administration 5) without radiation therapy 6) age: 20 <= and => 75 years old 7) performance status: 0-1(ECOG classification) 8) Expected survival period is longer than 13 weeks. 9) with sufficient function on the important organs WBC 3,000<= and =< 12,000 mm3/dl Neutrocyte 1,500mm3 <= Hemoglobin 8.0 g.dl <= Platelet 100,000/mm3 <= Total bilirubin within 1.5 times of normal range of each institute AST, ALT within 2.5 times of normal range in each institute Serum creatinin within normal range of each institute ECG normal range 10) written informed consents
Exclusion criteria
Exclusion criteria: 1. with interstitial pneumonitis or pulmonary fibrosis 2. cavity fluid which should be taken out 3. with double cancer and/or multiple cancer which excludes carcinoma in situ 4. with infectious disease, intestinal paralysis, or intestinal obstraction 5. under the condition of diarrhea (watery diarrhea) 6. under insulin therapy or uncontrolled DM 7. with ulcer on digestive organs 8. with ischemic cardiac disease 9. with psychological disorder which disturb the entry to the study 10. under HBs-Antigen(+), HCV antibody(+), or HIV antibody(+) 11. under continuous steroids therapy 12. with other severe diseases(cardiac failure, liver dysfunction, or renal dysfunction) 13. brain metastasis with some symptoms 14. pregnant and/or nursing women 15. with allergic history against medicines 16. doctors' stop not to register to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time To Progression(TTP), Time To Treatment Failure (TTF), Survival Time, Relative Dose Intensity | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Sakai City Hospital Director
Outcome results
None listed