A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC)
- Conditions
- advanced/recurrent colorectal cancer
- Registration Number
- JPRN-UMIN000001617
- Lead Sponsor
- CPT-11/TS-1 study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 30
Not provided
1. Serious drug hypersensitivity or a history of drug allergy 2. Plerral effusion, peritoneal fluid and pericardial fluid 3.Active infections 4. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 5.Intestines tube paralysis, intestinal obstruction and peptic ulcer 6. interstitial pnumonitis, pulmonary fibrosis 7.Need to treatment with flucytosine 8.Active concomitant malignancy 9.diabetic that cannot be controlled 10. symptomatic or asymptomatic but treated heart disease 11. histry of mental disturbances or cerebrovascular attach 12. under coutinuous steroid therapy 13. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 14.Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I : recommended dose Phase I I: Response rate
- Secondary Outcome Measures
Name Time Method