Phase II study of combination therapy with Irinotecan and S-1 in patients with progressive colorectal cancer after FOLFOX regimen

UMIN ID: UMIN000001342

Registered date:29/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable advanced/recurrent colorectal cancer
• Date of first enrollment: 2007/08/03
• Target sample size: 56
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Irinotecan+S-1, repeated every 3 weeks.

Outcome(s)

• Primary Outcome: RR
• Secondary Outcome: Safety, PFS, OS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Administering antithrobotic drug within 7 days 2. Serious complications (renal failure or hepatic failure) 3. Serious drug hypersensitivity or a history of drug allergy 4. Active concomitant malignancy 5. Active infections 6. High blood pressure and diabetic that cannot be controlled 7. symptomatic or asymptomatic but treated heart disease 8. interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 9. histry of mental disturbances or cerebrovascular attach 10. Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 11. Plerral effusion, peritoneal fluid and pericardial fluid 12. Symptomatic brain metastasis 13. Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 14. Need to treatment with atazanavir sulfate or flucytosine 15. under coutinuous steroid therapy 16. Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 17. on other clinical trial 18. Other conditions not suitable for this study

Related Information

• Primary Sponsor: KSCC
• Source(s) of Monetary Support: CReS