Phase II study of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab

Phase 2

• Conditions: metastatic colorectal cancer

• Registration Number: JPRN-UMIN000005228
• Lead Sponsor: Tokyo Women's Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-09
• Study Completion: 2013-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

1)Radiological evidence of CNS metastases or brain cancer 2)Complication of cerebrovascular disease or symptoms within 1 year 3) complication of GI perforation, or past history of perforation within 1 year 4) Uncontroled Gastrointestinal Ulcer 5) Uncontrolled Diarrhea 6) Receiving Atazanavir Sulfate 7)Paralytic or mechanical bowel obstruction 8) Evidence of bleeding diathesis or coagulopathy. 9) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS) 10) Clinically significant (i.e. active, CTCAEv4.0 >=Grade2) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 11) Uncontrolled Hypertension 12) Need to drain malignant coelomic fluid. 13) Evidence of interstinal lung disease, or pulmonary fibrosi 14) Uncontrolled infection 15) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 16) History of the serious hypersensitivity for Fluorouracil or bevacizumab 17) Treatment history of irinotecan 18) Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified