Phase II Study of FOLFIRI Plus Bevacizumab (AVASIRI) in Patients as Second Line Chemotherapy of Unresectable Colorectal Cancer

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: JPRN-UMIN000001060
• Lead Sponsor: ational Cancer Center Hospital, Gastrointestinal Oncology Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-01
• Study Completion: 2009-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1) Active double cancer 2) Serious drug hypersensitivity or a history of drug allergy 3) Active infections 4) Serious complications (e.g., intestinal tract paralysis, ileus, pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure or hepatic failure.) 5) Uncontrolled hypertension 6) Abnormal EKG 7) Severe ascites 8) Metastasis to the CNS 9) History or evidence of inherited bleeding diathesis 10) Coagulopathy with the risk of bleeding 11) Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism 12) HBs Ab positive, HCV At positive 13) Uncontrolled watery diarrhea 14) Major surgical procedure within 4 weeks 15) Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. 16) Judged ineligible for participation in the study by the investigator for safety reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified