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A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.

NCT ID: NCT00349336

Last Updated: 2012-09-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-11-30

Brief Summary

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This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

7.5mg/kg iv on day 1 of each 3 week cycle

XELOX

Intervention Type DRUG

As prescribed

2

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

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

FOLFOX-4

Intervention Type DRUG

As prescribed

Interventions

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bevacizumab [Avastin]

7.5mg/kg iv on day 1 of each 3 week cycle

Intervention Type DRUG

XELOX

As prescribed

Intervention Type DRUG

bevacizumab [Avastin]

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

Intervention Type DRUG

FOLFOX-4

As prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
* \>=1 target lesion.

Exclusion Criteria

* patients who have previously received systemic treatment for advanced or metastatic disease;
* patients who have received adjuvant treatment for non-metastatic disease in past 3 months;
* previous therapy with oxaliplatin or Avastin.
Minimum Eligible Age

18 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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Box Hill, , Australia

Site Status

Fitzroy, , Australia

Site Status

Sydney, , Australia

Site Status

Brampton, Ontario, Canada

Site Status

Hamilton, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Christchurch, , New Zealand

Site Status

Countries

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Australia Canada New Zealand

Other Identifiers

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NO20254

Identifier Type: -

Identifier Source: org_study_id