Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC) (SAFE)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin|
- Progression free survival [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Toxicity profiles [ Time Frame: 2 or 3 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy
Drug: Bevacizumab (Avastin)
Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)
Other Name: Bevacizumab (Avastin)
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 as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862342
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Songpa-gu, Korea, Republic of|
|Study Chair:||Tae Won Kim, M.D.||Asan Medical Center|