Status:

COMPLETED

Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC)

Lead Sponsor:

Asan Medical Center

Conditions:

Metastatic Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Bevacizumab beyond progression has been proven to be safe in the community setting (BRiTE) and in the post-marketing study (BEAT), and confirmed its efficacy and safety in the first line with all regi...

Detailed Description

Patients should have been treated with bevacizumab plus chemotherapy as a 1st line treatment, and after 1st progression, these patients will be accrued in this study of bevacizumab plus chemotherapy a...

Eligibility Criteria

Inclusion

  • Histologically documented colorectal adenocarcinoma
  • Progression during first-line bevacizumab containing chemotherapy within 3 months
  • No serious toxicity to bevacizumab of 1st line treatment
  • Unresectable metastases
  • Uni-dimensional measurable lesion(s) by RECIST
  • Age over 18 years old
  • ECOG 0-2
  • Adequate organ functions by clinical laboratory exams

Exclusion

  • Other tumor type than adenocarcinoma
  • CNS metastases
  • GI bleeding
  • Hypersensitivity to any of chemotherapeutic agents
  • Prior use of cetuximab or other targeted agents other than bevacizumab
  • Major surgery within 6 weeks
  • Other serious illness

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2012

Estimated Enrollment :

78 Patients enrolled

Trial Details

Trial ID

NCT00862342

Start Date

January 1 2009

End Date

June 1 2012

Last Update

July 17 2012

Active Locations (1)

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1

Asan Medical Center

Seoul, Songpa-gu, South Korea