A phaseII study of irinotecan with bevacizumab as third line treatment for patients with metastatic colorectal cancer after failure to irinotecan who have progressed on bevacizumab with oxaliplatin-based chemotherapy in second line.
- Conditions
- colorectal cancer
- Registration Number
- JPRN-UMIN000009910
- 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)Radiological evidence of CNS metastases or brain cancer. (3) Multiple primary cancers within 5 years. (4) Complication of cerebrovascular disease or symptoms within 1 year. (5)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. (6) The patient who is planning the surgical treatment during trial. (7)Administering antithrombotic drug within 10 days. (8)Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS). (9) Evidence of bleeding diathesis or coagulopathy. (10)Active gastrointestinal ulcer (11)Current or previous (within the last 1 year) history of GI perforation. (12)Non healing fracture (13)Renal failure to be treated,3+ or higher proteinuria within 2 weeks prior to entry. (14)Uncontrolled Hypertension (15)Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction. (16)History of the serious hypersensitivity for irinotecan or bevacizumab. (17)Uncontrolled diarrhea (18)Evidence of interstinal lung disease, or pulmonary fibrosis. (19)History of organ transplantation. (20)Uncontrolled infection (21)Pregnant or lactating women or women of childbearing potential. (22) Men without the intention of preventing conception. (23) Other conditions not suitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method