A multicenter phase I/II study of irinotecan (CPT-11) and S-1 combination chemotherapy for metastatic colorectal cancer (CRC)

UMIN ID: UMIN000001617

Registered date:06/01/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: advanced/recurrent colorectal cancer
• Date of first enrollment: 2004/02/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Irinotecan+S-1, repeated every 3 weeks.

Outcome(s)

• Primary Outcome: Phase I : recommended dose Phase I I: Response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: CPT-11/TS-1 study group
• Source(s) of Monetary Support: CPT-11/TS-1 study group