A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000009911
- Lead Sponsor
- Tsuchiura kyodo general hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
(1)Need to drain malignant celomic fluid. (2)Jaundice (3)Paralytic or mechanical bowel obstruction. (4)Receiving Atazanavir Sulfate (5)Radiological evidence of CNS metastases or brain cancer. (6)Multiple primary cancers within 5 years. (7)Complication of cerebrovascular disease or symptoms within 1 year. (8)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. (9)Administering antithrombotic drug within 10 days. (10)Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). (11)Evidence of bleeding diathesis or coagulopathy. (12)Active gastrointestinal ulcer (13)Current or previous (within the last 1 year) history of GI perforation. (14)Non healing fracture (15)Renal failure to be treated,3+ or higher proteinuria within 2 weeks prior to entry. (16)Uncontrolled Hypertension (17)Uncontrolled diabetes mellitus (18)Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. (19)History of the serious hypersensitivity for bevacizumab. (20)Evidence of interstinal lung disease, or pulmonary fibrosis. (21)History of organ transplantation. (22)Treatment history of irinotecan. (23)Other conditions not suitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I part Estimated the dose limiting toxicities in 1st cycle. Phase II part Progression Free Survival
- Secondary Outcome Measures
Name Time Method Safety overall survival overall response rate disease control rate