Phase1study of a combination of CPT-11 and TS-1 and bevacizumab in patients with metastatic colon cancer

UMIN ID: UMIN000001219

Registered date:30/06/2008

Basic Information

• Health condition(s) or Problem(s) studied: metastatic colorectal cancer
• Date of first enrollment: 2008/05/01
• Target sample size: 24
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): We use three drugs (CPT-11, TS-1, bevacizumab) for this trial. The treatment schedule of CPT-11 and bevacizumab are administrated on day 1 and day 15, and of TS-1 is administrated between day1 and day 21. The dosage of CPT-11 are 80-110/m2, and of TS-1 are 80-120mg (the dosage are calculated by body surface area), and of bevacizumab are 5 or 7mg/kg.

Outcome(s)

• Primary Outcome: safety
• Secondary Outcome: efficacy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria were as follows; patients were not eligible for this study if they had a previous serious medical illness or allergy for drugs; had active double cancer; had active infection disease (over 38.0C fever); had perforation of the digestive tract, gastrointestinal paralysis, bowel blockage or history within 1 year before entry; had hypertension which could not control with drug therapy; had serious complication (e.g. interstitial lung disease, lung fibrosis, heart failure, kidney failure, hepatic failure, diabetes mellitus which could not be controlled); had pleural effusion or abdominal dropsy which need therapy; had water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity; took flucytosine or atazanavir; had brain metastasis; were pregnancy or lactation; could not joint this trial because of mental disorder or psychiatric symptom; were systemically-administered of steroids; were uric protein greater than 2 positive ; were thrombosis; were brain infarction, myocardial infarction or lung infarction before entry; were operated or performed dissected biopsy within 4 weeks before entry; were administered antiplatelet agent for chronic rheumatoid arthritis; were bleeding tendency, coagulation disorder, abnormality of coagulation factor, or administered anticoagulant; except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.

Related Information

• Primary Sponsor: Department of Surgery, Suita Municipal Hospital
• Source(s) of Monetary Support: Osaka Cancer Research Foundation