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A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum.

NCT ID: NCT01169558

Last Updated: 2016-12-08

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

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-07-31

Brief Summary

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This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.

Detailed Description

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Conditions

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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 will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.

Fluoropyrimidine-based Chemotherapy

Intervention Type DRUG

Fluoropyrimidine-based chemotherapy administered according to standard of care.

Interventions

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Bevacizumab

5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.

Intervention Type DRUG

Fluoropyrimidine-based Chemotherapy

Fluoropyrimidine-based chemotherapy administered according to standard of care.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Previously untreated metastatic colon or rectal cancer;
* Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.

Exclusion Criteria

* Prior chemotherapy for metastatic colon or rectal cancer;
* Planned radiotherapy for underlying disease;
* central nervous system metastases;
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
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_CHAIR

Hoffmann-La Roche

Locations

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Belo Horizonte, , Brazil

Site Status

Belo Horizonte, , Brazil

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Belo Horizonte, , Brazil

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Brasília, , Brazil

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Brasília, , Brazil

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Campinas, , Brazil

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Campinas, , Brazil

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Caxias do Sul, , Brazil

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Curitiba, , Brazil

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Curitiba, , Brazil

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Fortaleza, , Brazil

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Ijuí, , Brazil

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João Pessoa, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Recife, , Brazil

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Ribeirão Preto, , Brazil

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Rio de Janeiro, , Brazil

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Rio de Janeiro, , Brazil

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Salvador, , Brazil

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Salvador, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

Site Status

São Paulo, , Brazil

Site Status

São Paulo, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ML20552

Identifier Type: -

Identifier Source: org_study_id