A phase I study of alternate-day administration of S-1 plus leucovorin with bevacizumab in patients with refractory metastatic colorectal cancer.
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000016094
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
(1) Active multiple malignancy (2) History of severe drug-induced hypersensitivity (3) Symptomatic brain metastasis (4) Active infection (5) Interstitial pneumonia or pulmonary fibrosis (6) Serious complications (renal failure, liver failure, severe cardiac disease, uncontrolled diabetes, uncontrolled hypertension, ileus). (7) massive pleural or abdominal effusion (8) Diarrhea (9) Administration of phenytoin or flucytosine (10) Systemic administration of steroid (11) Thromboembolism (grade 3 or higher), myocardial infarction, brain infarction, or pulmonary embolism within 6 months before enrollment (12) Any major surgery or open biopsy within 4 weeks before enrollment (13) Systemaic administration of antiplatelet drugs or NSAIDs (14) Bleeding diathesis, coagulopathy or administration of anticoagulation (15) Active peptic ulcer (16) History of gastrointestinal perforation within 1 year before enrollment (17) Clinically significant mental disorder (18) Positive for HBs antigen (19) Women who are pregnant or patients who are unwilling to avoid pregnancy (20) Patients who are inappropriate for the study in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method