Bi-weekly capecitabine and oxaliplatin plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000007190
- Lead Sponsor
- Epidemiological and Clinical research Information Network (ECRIN)
- Brief Summary
RESULTS: A total of 51 patients were enrolled from 14 institutions from December 2011 to July 2012. The median age was 66 (range=38-85) years, 29 (56.9%) had colonic cancer and 22 (43.1%) had rectal cancer in this study. Pertinent grade 3/4 toxicities were neutropenia (13.7%), peripheral neuropathy (13.7%), hypertension (13.7%), gastrointestinal perforation (3.9%), and hand-foot syndrome (5.9%). The response rate was 51% (one complete and 25 partial responses). Median PFS and TTP were 344 days and 196 days, respectively. Median overall survival has not been reached yet.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1. Serious renal dysfunction 2. Serious drug hypersensitivity or a history of drug allergy 3. Active multiple primary neoplasm 4. Active infections 5. Serious heart disease 6. History of thrombosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema 7. Fresh gastrointestinal hemorrhage, intestinal obstruction or peptic ulcer 8. Pleural effusion, peritoneal fluid and pericardial fluid 9. Symptomatic brain metastasis 10. History of mental disturbances or cerebrovascular disorder 11. Uncontrolled high blood pressure and diabetes 12. Uncontrolled diarrhea 13. Serious non-healing wound and/or major surgical procedure within 4 weeks prior to enrollment 14. Traumatic fracture not healed 15. Bleeding tendency and anti-platelets therapy (including aspirin and NSAIDS) 16. Pregnant or possibly pregnant, and nursing women 17. Peripheral neuropathy 18. Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Response rate Overall survival Time to treatment failure Relative dose intensity Safety