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A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer

NCT ID: NCT00700570

Last Updated: 2016-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-11-30

Brief Summary

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This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

5mg/kg iv on day 1 of each 2 week cycle.

capecitabine [Xeloda]

Intervention Type DRUG

1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle

oxaliplatin

Intervention Type DRUG

85mg/m2 iv on day 1 of each 2 week cycle

Interventions

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bevacizumab [Avastin]

5mg/kg iv on day 1 of each 2 week cycle.

Intervention Type DRUG

capecitabine [Xeloda]

1000mg/m2 iv on days 1-5 and 8-12 of each 2 week cycle

Intervention Type DRUG

oxaliplatin

85mg/m2 iv on day 1 of each 2 week cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \<=75 years of age;
* chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;
* \>=1 measurable lesion;
* ECOG status 0-2.

Exclusion Criteria

* prior exposure to Avastin;
* clinical or radiological evidence of CNS metastases;
* uncontrolled hypertension, or clinically significant cardiovascular disease;
* ongoing treatment with aspirin (\>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Kaohsiung City, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML21209

Identifier Type: -

Identifier Source: org_study_id