Clinical efficacy and biomarker assessment of Capecitabine plus oxaliplatin (XELOX) in combination with Bevacizumab as second-line therapy in patients with advanced or recurrent colorectal cancer after failure to irinotecan. Multi-center phase II Study.
- Conditions
- Patients with advanced or recurrent colorectal cancer after failure to irinotecan.
- Registration Number
- JPRN-UMIN000005184
- Lead Sponsor
- Department of Surgery, School of Medicine, Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 33
Not provided
(1) Hypersensitivity or History of the severe hypersensitivity for capecitabine, oxaliplatin or bevacizumab. (2) Prior abdominal irradiation for colorectal cancer. (3) CNS metastases or brain cancer confirmed by imaging (When it is suspected, imaging confirmation is required). (4) Complication of cerebrovascular disease or its symptoms within 1 year. (5) With sever complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, hypertension, cardiac failure, renal failure, liver dysfunction, and so on). (6) With complication of history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. (7) Massive pleural or ascites that required drainage. (8) Uncontrolled peptic ulcer. (9) Uncontrolled diarrhea. (10) Uncontrolled infection. (11) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor (12) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low-dose of aspirin.) (13) Active multiple primary cancer. (14) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (15) With mental disorder or psychological symptoms which disturb registration to this study. (16) Not appropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 6-month Progression free survival rate
- Secondary Outcome Measures
Name Time Method Response rate Disease control rate Progression free survival Overall survival Time to treatment failure Safety Exploring several predictable biomarkers