Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer

NCT ID: NCT00378066

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab

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

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

Bevacizumab, Capecitabine, Oxaliplatin

Interventions

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Bevacizumab

Bevacizumab, Capecitabine, Oxaliplatin

Intervention Type DRUG

Other Intervention Names

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Capecitabine, Oxaliplatin

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
* Known allergy to study drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae Won Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae Won Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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National Cancer Center

Goyang, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Yonsei University Hospital

Seoul, , South Korea

Site Status

Bundang Seoul National University Hospital

Sungnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMC-ONCGI-0277

Identifier Type: -

Identifier Source: org_study_id

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