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

July 16, 2012 updated by: Tae Won Kim, Asan Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 6 weeks
6 weeks
Toxicity profiles
Time Frame: 2 or 3 weeks
2 or 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Study Chair: Tae Won Kim, M.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (Estimate)

March 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC-2008-0487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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