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

Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00862342

Acronym

SAFE

Enrollment

Registered

2009-03-16

Start date

2009-01-31

Completion date

2012-06-30

Last updated

2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer, Bevacizumab

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 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.

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 as a 2nd line treatment, and the combined chemotherapy will be chosen by physician's decision in consider with previous chemotherapy.

Interventions

DRUGBevacizumab (Avastin)

Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression free survival	6 weeks

Secondary

Measure	Time frame
Overall survival	6 weeks
Toxicity profiles	2 or 3 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026