Phase II study of Bevacizumab in combination with FOLFIRI as second-line therapy for patients with metastatic colorectal cancer who have progressed on Bevacizumab with Oxaliplatin-based chemotherapy
- Conditions
- metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000002407
- Lead Sponsor
- Sapporo City General Hospital
- 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.interstitial lung disease, or pulmonary fibrosis 16.uncontrolled infection 17.history of organ transplantation 18.diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 19.pregnancy (positive serum pregnancy test) and lactation 20.serious drug hypersensitivity or a history of drug allergy 21.history of adverse events related to fluorouracil 22.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 Progression free survival
- Secondary Outcome Measures
Name Time Method Safety,Overall response rate,Overall survival,Overall survival from 1st line