A Multicenter, Clinical Phase II study of FOLFOXIRI with Bevacizumab As First-line Therapy in Patients with Metastatic Colorectal Cancer.
- Conditions
- Patients with metastatic colorectal cancer.
- Registration Number
- JPRN-UMIN000013797
- Lead Sponsor
- EPS Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 65
Not provided
1. Previously treated with irradiation to bone marrow constituting 20% or more of irradiation field. 2. Untreated brain metastases or spinal cord compression or primary brain tumors. 3. History of CNS disease.[except for asymptomatic Lacunar stroke] 4. Requiring chronic systemic corticosteroid treatment. 5. Current or recent ongoing treatment with anticoagulants. 6. Clinically significant cardiovascular disease for example cerebrovascular accidents, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication. 7. Treatment with any investigational drug within 4 weeks. 8. Patient with Uncontrolled hypertension, Uncontrolled diabetes, Uncontrolled diarrhea->=grade 1 peripheral neuropathy, Active peptic ulcer, Non-healing wound, Clinically important diseases. 9. Major surgical procedure within 28 days prior to study treatment start, open biopsy, or significant traumatic injury, or anticipation of the need for major surgical procedure. 10. Lack of physical integrity of the upper gastrointestinal tract. 11. Pregnant women, lactating woman , positive by pregnancy test , wishing to become pregnant, and Sexually active males. 12. Hepatitis B or hepatitis C . Evidence of HIV infection. 13. Previous Chemotherapy for other organs. 14. Other active co-existing malignancies. 15. History / Presence of thrombosis within 1 year requiring medication. 16. History / Presence of paralytic ileus, obstruction or gastrointestinal perforation. 17. Malignant coelomic fluid required drainage. 18. History of allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications. 19. History of fluoropyrimidine severe side effects caused by DPD defect. 20. Interstitial pneumonitis or pulmonary fibrosis. 21. Evidence or requiring systemic treatment for Infectious disease. 22. Patient who is judged by the investigator to be inappropriate for study participation for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) at 10 months; by investigator-reported measurements.
- Secondary Outcome Measures
Name Time Method Response rate (RR) ; by investigator-reported measurements, by central review PFS; by central review Overall survival (OS) Efficacy by RAS status ; RR,PFS,OS Incidence of adverse events Time to treatment-failure Completion rate in Induction treatment Relative Dose Intensity Treatment duration