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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 regimens of chemotherapy. A total of 1,953 patients were treated in BRiTE. At median follow-up of 17.5 mo, there were 1,369 1st PD and 839 deaths. Among patients with 1st PD, 65.2% received any 2nd-line chemotherapy, 34.8% received cetuximab, and 53.8% received BBP. In a multivariate analysis, Bevacizumab beyond first progression and exposure to any 2nd-line chemotherapy were independently associated with increased overall survival (both p < 0.0001). Bevacizumab beyond progression appears to be associated with longer overall in BRiTE.

The investigators planned a prospective study to prove this phenomenon of bevacizumab beyond progression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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