Phase II study of bevacizumab combined with oral leucovorin plus UFT for elderly patients with metastatic colorectal cancer.
- Conditions
- advanced and recurrent colorectal cancer
- Registration Number
- JPRN-UMIN000003515
- Lead Sponsor
- Tukuba cancer clinical trial group Shikoku gastrointestinal oncology study group
- Brief Summary
Of the 55 patients enrolled. Their median age was 80 years (range, 75-87 years) The median PFS was 8.2 months (95% confidence interval [CI], 6.2-10 months). UFT/LV (3 weeks of therapy and 1 week without) combined with biweekly bevacizumab is a tolerable and effective treatment option for elderly patients (aged over 75 years) with metastatic colorectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Not provided
1)Concurrent treatment with prohibited medications, including phenytoin 2)Administration contraindication of UFT, leucovorin and bevacizumab 3)Serious infection 4)HBsAg potitive 5)Active double cancer 6)Uncontrolled hypertention 7)Severe complications 8)Massive pleural or abdominal effusion 9)Patient with the diarrhea 10)Brain metastasis 11)Uric protein 2+ 12)Men of the fertility hope 13)Pregnant or lactating female at any time during study 14)Systemic administration of corticosteroids 15)Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction 16)Patients who underwent surgery within 4 weeks 17)Systemic administration of antiplatelet drug 18)Patients with known bleeding disorders or clotting disorder 19)Severe mental illness 20)Patients who are judged inappropriate for the entry into the study by the investigator
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 survival Response rate