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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bevacizumab (Avastin)
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring colorectal cancer, Bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Overall survival
Toxicity profiles

Full Information

First Posted
March 13, 2009
Last Updated
July 16, 2012
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00862342
Brief Title
Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
colorectal cancer, Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Arm Description
Bevacizumab continuation plus chemotherapy in patients who have failed previous bevacizumab plus other chemotherapy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab (Avastin)
Intervention Description
Bevacizumab plus chemotherapy (chemotherapy will be chosen by physician's decision)
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
6 weeks
Title
Toxicity profiles
Time Frame
2 or 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Won Kim, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22782485
Citation
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 progressed after upfront bevacizumab plus doublet combination chemotherapy. Invest New Drugs. 2013 Feb;31(1):183-91. doi: 10.1007/s10637-012-9853-3. Epub 2012 Jul 11.
Results Reference
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Post-First Progression Use of Bevacizumab in Metastatic Colorectal Cancer (mCRC)

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