dose finding study of irinotecan for UGT1A1 homozygnous group

UMIN ID: UMIN000002353

Registered date:01/10/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: gastric cancer,colorectal cancer,lung cancer,ovarian cancer,cervical cancer and brest cancer
• Date of first enrollment: 2009/10/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Administraion of irinotecan is twice for 4 weeks . Adjusted dosage is determined from 100or125 mg/sqm in the heterozygous group .

Outcome(s)

• Primary Outcome: adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)History of serious drug allergy 2)Active concomitant malignancy 3)Prior extensively irradiation for abdominal or bowel bone marrow 4)Symptomatic brain metastasis 5)Systemic continual use of steroids 6)Active infection 7)Persistent diarrhea (watery stool) 8)Intestinal obstraction or paralytic ileus 9)Interstitial pneumonia or pulmonary fibrosis 10)Massive pleural, pericardial effusion or asites that required drainage 11)Need to treatment with atazanavir sulfate 12)Uncontrolled diabetes mellitus 13)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment 14)Psychological disease deemed to unacceptable for inclusion to the study 15)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy 16)Other concominant medical condition deemed to inadequate for inclusion to the study

Related Information

• Primary Sponsor: kobe University Hospital and Graduate School of Medicine
• Source(s) of Monetary Support: kobe University Hospital and Graduate School of Medicine