Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer

UMIN ID: UMIN000000613

Registered date:01/03/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced/recurrent colorectal cancer
• Date of first enrollment: 2007/02/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): It takes 2 weeks for one course and that is to be repeated. Dose schedule for one course CPT-11 150mg/ m2/day Day 1 5-FU 500 mg/m2/day Day 1 l-LV 15 mg/m2/day Day 1 UFT 300 mg/m2/day Day 1-8 morning LV 75 mg/day Day 1-8 morning

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: adverse events, overall survival,progression-free survival,time to treatment failure.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)interstitial pneumonitis or pulmonary fibrosis 2)with cavity fluid to be treated 3)with present active double cancer or D.B. diagnosed less than 5 years before, excluding cured cancer in situ or skin cancer 4)ileus 5)watery diarrhea 6)D.M. which needs insulin or uncontrolled D.M. 7)With other diseases which influence to the study (heart diseases, liver dysfunction, renal failure) 8)brain metastasis with some symptoms 9)pregnant women or suspected women 10)receiving atazanavir sulfate 11)Receiving steroids treatment 12)With experience of drug anaphylaxis shock 13)Doctor stop due to miscellaneous factors

Related Information

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