NCT00862342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

March 13, 2009

Last Update Submit

July 16, 2012

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancerBevacizumab

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    6 weeks

Secondary Outcomes (2)

  • Overall survival

    6 weeks

  • Toxicity profiles

    2 or 3 weeks

Study Arms (1)

Bevacizumab

EXPERIMENTAL

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

Drug: Bevacizumab (Avastin)

Interventions

Bevacizumab (Avastin)DRUG

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

Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

Related 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 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.

    PMID: 22782485RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Tae Won Kim, M.D.

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 16, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2012

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

KR(1)