Phase II Study of Bevacizumab, Capecitabine and Oxaliplat... | NCT00378066

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

NCT00378066

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jan 23, 2013Estimated

Enrollment

49Actual

Phase

Phase 2

Conditions

Metastatic Colorectal Cancer

Interventions

Bevacizumab

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Aug 2006Actual

Completion Date

Oct 2008Actual

First Submitted Date

Sep 18, 2006

First Submission Date that Met QC Criteria

Sep 18, 2006

First Posted Date

Sep 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2013

Last Update Posted Date

Jan 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bevacizumab	Active Comparator	Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment	Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bevacizumab	Drug	Bevacizumab, Capecitabine, Oxaliplatin	Bevacizumab

Measure	Description	Time Frame
time to progression		6 months

Measure	Description	Time Frame
overall survival, safety, response		1 year

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tae Won Kim, M.D.	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center		Goyang			South Korea
Asan Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
C519688	XELOX

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided