NCT00378066

Brief Summary

The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

6 active sites

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

August 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

Same day

First QC Date

September 18, 2006

Last Update Submit

January 21, 2013

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • time to progression

    6 months

Secondary Outcomes (1)

  • overall survival, safety, response

    1 year

Study Arms (1)

Bevacizumab

ACTIVE COMPARATOR

Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment

Drug: Bevacizumab

Interventions

BevacizumabDRUG

Bevacizumab, Capecitabine, Oxaliplatin

Also known as: Capecitabine, Oxaliplatin
Bevacizumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically documented colorectal adenocarcinoma
  • ECOG performance status of 2 or lower
  • Adequate bone marrow function
  • Adequate kidney function
  • Adequate liver function
  • Informed consent

You may not qualify if:

  • Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
  • Known allergy to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

National Cancer Center

Goyang, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University Hospital

Seoul, South Korea

Location

Bundang Seoul National University Hospital

Sungnam, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabXELOX

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

    PRINCIPAL INVESTIGATOR

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

September 18, 2006

First Posted

September 19, 2006

Study Start

August 1, 2006

Primary Completion

August 1, 2006

Study Completion

October 1, 2008

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

KR(6)