Phase II Trial of Bevacizumab in Combination with XELOX in Colorectal Cancer Patients with Liver Metastases (H2, H3)
- Conditions
- colorectal liver metastases
- Registration Number
- JPRN-UMIN000002897
- Lead Sponsor
- iigata Colorectal cancer Chemotherapy Study Group (NCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1.clinical or radiological evidence of CNS metastases. 2.current or previous (within the last 1 year) history of cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to Day 0 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.serious non-healing ulcer 7.evidence of bleeding diathesis or coagulopathy. 8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes 9.ongoing treatment with aspirin (> 325 mg/day) 10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 11.uncontrolled hypertension 12. serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment 13.uncontrolled pleural and/or peritoneal effusion 14.past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - In-situ carcinoma of the cervix 15. neuropathy >= Grade 1 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 16.interstitial lung disease, or pulmonary fibrosis 17. diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 18.uncontrolled infection 19.history of organ transplantation 20.pregnancy (positive serum pregnancy test) and lactation 21.serious drug hypersensitivity or a history of drug allergy 22.history of adverse events related to fluorouracil 23.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method resection rate of liver metastases
- Secondary Outcome Measures
Name Time Method R0 resection rate of liver metastases, overall response rate, progression free survival, relapse free survival, overall survival, adverse events, sinusoidal injury