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

NCT ID: NCT02582970

Last Updated: 2017-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-04-30

Brief Summary

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This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

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 + Chemotherapy

Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

5-Fluorouracil

Intervention Type DRUG

Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.

Bevacizumab

Intervention Type DRUG

Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.

Irinotecan

Intervention Type DRUG

Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Interventions

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Oxaliplatin

Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Intervention Type DRUG

5-Fluorouracil

Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.

Intervention Type DRUG

Bevacizumab

Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.

Intervention Type DRUG

Irinotecan

Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.

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 IV 5-fluorouracil-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 prior to study start
* Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
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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Chai Yi, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML18436

Identifier Type: -

Identifier Source: org_study_id

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