A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

NCT ID: NCT00642577

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-12-31

Brief Summary

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This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 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

5mg/kg iv every 2 weeks

irinotecan

Intervention Type DRUG

125mg/m2 iv weekly for 4 weeks of each 6 week cycle

leucovorin

Intervention Type DRUG

20mg/m2 iv weekly for 4 weeks of each 6 week cycle

fluorouracil

Intervention Type DRUG

500mg/m2 iv weekly for 4 weeks of each 6 week cycle

2

Group Type ACTIVE_COMPARATOR

irinotecan

Intervention Type DRUG

125mg/m2 iv weekly for 4 weeks of each 6 week cycle

leucovorin

Intervention Type DRUG

20mg/m2 iv weekly for 4 weeks of each 6 week cycle

fluorouracil

Intervention Type DRUG

500mg/m2 iv weekly for 4 weeks of each 6 week cycle

Interventions

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bevacizumab [Avastin]

5mg/kg iv every 2 weeks

Intervention Type DRUG

irinotecan

125mg/m2 iv weekly for 4 weeks of each 6 week cycle

Intervention Type DRUG

leucovorin

20mg/m2 iv weekly for 4 weeks of each 6 week cycle

Intervention Type DRUG

fluorouracil

500mg/m2 iv weekly for 4 weeks of each 6 week cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
* \>=1 measurable lesion;
* ECOG performance status of \<=1.

Exclusion Criteria

* prior systemic therapy for advanced or metastatic disease;
* adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
* other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
* clinically significant cardiovascular disease in past 6 months.
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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Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Chongqing, , China

Site Status

Guangdong, , China

Site Status

Guangzhou, , China

Site Status

Nanjing, , China

Site Status

Qingdao, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Tianjin, , China

Site Status

Wuhan, , China

Site Status

Countries

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China

Other Identifiers

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BO20696

Identifier Type: -

Identifier Source: org_study_id