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

Metastatic Colorectal Cancer Clinical Trial

— SAFE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862342
• Other study ID #: AMC-2008-0487
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2009
• Last updated: July 16, 2012
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Bevacizumab (Avastin)
Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Hong YS, Lee J, Kim KP, Lee JL, Park YS, Park JO, Park SH, Kim SY, Baek JY, Kim JH, Lee KW, Kim TY, Kim TW. Multicenter phase II study of second-line bevacizumab plus doublet combination chemotherapy in patients with metastatic colorectal cancer progresse — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		6 weeks	Yes
Secondary	Overall survival		6 weeks	Yes
Secondary	Toxicity profiles		2 or 3 weeks	Yes