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

Sponsor
Asan Medical Center
Study ID
NCT00862342
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab (Avastin) — DRUG
    Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)

Study Details

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.

Key Dates

First listed
Mar 16, 2009
Start date
Jan 31, 2009
Status verified
Jul 2012
Primary completion
Dec 31, 2010
Completion
Jun 30, 2012

Study Design

Enrollment
78 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy

Primary Outcome Measure

Progression free survival [ Time Frame: 6 weeks ]

Related Studies