A Phase I /II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.

Phase 1

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000003990
• Lead Sponsor: Japanese foundation for cancer research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-25
• Study Completion: 2014-08-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Treatment with tegafur gimestat otastat potassium within 7 days (2) Need to drain malignant coelomic fluid. (3) Jaundice (4) Paralytic or mechanical bowel obstruction (5) Receiving Atazanavir Sulfate (6) Radiological evidence of CNS metastases or brain cancer (7) Multiple primary cancer within 5 years. (8) Complication of cerebrovascular disease or symptoms within 1 year. (9) Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week. (10) Administering antithrombotic drug within 10 days. (11) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS) (12) Evidence of bleeding diathesis or coagulopathy. (13) Active gastrointestinal ulcer (14) Current or previous (within the last 1 year) history of GI perforation (15) Non healing fracture (16) Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry (17)Uncontrolled Hypertension (18) Uncontrolled diabetes mellitus (19) Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction (20) History of the serious hypersensitivity for Fluorouracil or bevacizumab (21) Evidence of interstinal lung disease, or pulmonary fibrosis (22) History of organ transplantation (23) Treatment history of irinotecan (24) Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified