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

Phase 1
Conditions
metastatic colorectal cancer
Registration Number
JPRN-UMIN000001219
Lead Sponsor
Department of Surgery, Suita Municipal Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Sex
All
Target Recruitment
24
Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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