A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-05-31

Brief Summary

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This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m\^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m\^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.

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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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Bevacizumab+capecitabine+oxaliplatin

Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

Bevacizumab was supplied as a solution in single-use vials.

Capecitabine

Intervention Type DRUG

Capecitabine was supplied as film-coated tablets.

Oxaliplatin

Intervention Type DRUG

Oxaliplatin was supplied as a lyophilized powder in vials.

Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C

Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m\^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m\^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab was supplied as a solution in single-use vials.

Capecitabine

Intervention Type DRUG

Capecitabine was supplied as film-coated tablets.

Oxaliplatin

Intervention Type DRUG

Oxaliplatin was supplied as a lyophilized powder in vials.

Interventions

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Bevacizumab

Bevacizumab was supplied as a solution in single-use vials.

Intervention Type DRUG

Capecitabine

Capecitabine was supplied as film-coated tablets.

Intervention Type DRUG

Oxaliplatin

Oxaliplatin was supplied as a lyophilized powder in vials.

Intervention Type DRUG

Other Intervention Names

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Avastin Xeloda Eloxatin

Eligibility Criteria

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Inclusion Criteria

* Adult patients, ≥ 18 years of age.
* Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.
* At least 1 measurable lesion.
* Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.

Exclusion Criteria

* Previous treatment with Avastin.
* Previous systemic treatment for advanced or metastatic disease.
* clinically significant cardiovascular disease.
* Daily chronic treatment with high doses of aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory drugs.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No