Clinical efficacy and safety assessment of high-dose Bevacizumab plus Fluorouracil and Leucovorin (sLV5FU2) in patients with standard chemotherapy refractory metastatic colorectal cancer. phase II multicenter trial.
- Conditions
- Metastatic colorectal cancer patients who have been either refractory to or intolerant of prior all approved standard chemotherapy.
- Registration Number
- JPRN-UMIN000009802
- Lead Sponsor
- The University of Tokyo, Graduate School of Medicine. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 25
Not provided
(1) Hypersensitivity or history of the severe hypersensitivity for Bevacizumab, Fluorouracil and Leucovorin. (2) Prior abdominal non-local irradiation for colorectal cancer. (3) Complication of cerebrovascular disease or its symptoms within 1 year. (4) With sever complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, hypertension, cardiac failure, renal failure, liver dysfunction, and so on). (5) With complication of history of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year. (6) Massive pleural or ascites that required drainage. (7) Uncontrolled Hypertension. (8) Uncontrolled peptic ulcer. (9) Uncontrolled diarrhea. (10) Uncontrolled infection. (11)Diathesis of bleeding (history of hemoptysis, including cavitation and / or necrosis in lung metastasis confirmed by imaging), coagulopathy or abnormality of coagulation factor. (12) Patient With colonic stent. (13) Administrated antithrombotic drug or drug affected to congealing fibrinogenolysis system within 14 days before enrollment (Except for low-dose of aspirin.) (14) Active multiple primary cancer. (15) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (16) With mental disorder or psychological symptoms which disturb registration to this study. (17) Not appropriate for the study at the physician's assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall survival Overall survival in patients with or without KRAS mutations. Progression-free survival in patients with or without KRAS mutations. Progression-free survival in patients with or without metastasectomy Response rate Disease control rate Time to treatment failure Safety