Phase II study of a combination of modified CPT-11 and 5-FU/l-LV (mJIFL) in patients with meatastatic colorectal cancer

UMIN ID: UMIN000000727

Registered date:08/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Meatastatic colorectal cancer
• Date of first enrollment: 2006/07/01
• Target sample size: 54
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 required.

Outcome(s)

• Primary Outcome: Response Rate
• Secondary Outcome: Time To Progression(TTP), Time To Treatment Failure (TTF), Survival Time, Relative Dose Intensity

Key inclusion & exclusion criteria

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

Related Information

• Primary Sponsor: OGSG
• Source(s) of Monetary Support: NPO Osaka Chinical Study Supporting Organization