Metastatic colorectal cancer patients who have been either refractory to or intolerant of prior all approved standard chemotherapy.
Conditions
Interventions
High-dose Bevacizumab + sLV5FU2 Bevacizumab 10mg/kg (d.i.v) l-LV 200mg/m2 (d.i.v) 5-FU 400mg/m2 (b.i.v) 5-FU 2400mg/m2 (c.i.v) Every 2weeks
Sponsors
The University of Tokyo, Graduate School of Medicine. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histological confirmation of colorectal cancer. (2) Metastatic colorectal cancer patients with KRAS mutations who have been either refractory to or intolerant of prior Oxaliplatin , Irinotecan, Bevacizumab therapies (3) Metastatic colorectal cancer patients without KRAS mutations who have been either refractory to or intolerant of prior Oxaliplatin , Irinotecan , Bevacizumab , anti EGFR therapies (4) 20 years old or more when received informed consent. (5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) : 0 - 1. (6) With estimative lesion observed in imaging (measurable lesions in RECIST criteria [ver.1.1] ) (7) Life expectancy estimated 3 months, and more. (8) Vital organ functions (listed below) are preserved within 14 days prior to entry. Neutrophil count >=1500/mm3 and =<12,000/mm3) Platelets >=75,000/mm3 Hemoglobin >=8.0g/dl Total bilirubin <=2.0g/dl AST and ALT <=100IU/l (<=200IU/l in case of liver metastasis) Serum creatinine < upper limit of normal (ULN) *1.5 Urinary protein <=grade1 (+1) (9) Written informed consent.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasaru Oba
The University of Tokyo, Graduate School of Medicine Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Outcome results
None listed