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. - 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. (NOBLE Study)

The University of Tokyo, Graduate School of Medicine. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery0 sites25 target enrollmentJanuary 18, 2013

ConditionsMetastatic colorectal cancer patients who have been either refractory to or intolerant of prior all approved standard chemotherapy.

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Metastatic colorectal cancer patients who have been either refractory to or intolerant of prior all approved standard chemotherapy.
Sponsor: The University of Tokyo, Graduate School of Medicine. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Enrollment: 25
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 18, 2013

End Date

January 1, 2016

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The University of Tokyo, Graduate School of Medicine. Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery

Eligibility Criteria

Inclusion Criteria

Not provided

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.