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A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer

NCT00118755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2011-03-03

Study results available
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Summary

This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m\^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m\^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m\^2 po bid on Days 1-7, oxaliplatin 85 mg/m\^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Conditions

Interventions

DRUG

capecitabine

850 mg/m\^2 po bid on Days 1-14 of each 3-week cycle

DRUG

Oxaliplatin

130 mg/m\^2 IV on Day 1 of each 3-week cycle

DRUG

bevacizumab

7.5 mg/kg IV on Day 1 of each 3-week cycle

DRUG

capecitabine

1500 mg/m\^2 po bid on Days 1-7 of each 2-week cycle

DRUG

Oxaliplatin

85 mg/m\^2 IV on Day 1 of each 2-week cycle

DRUG

bevacizumab

5 mg/kg IV on Day 1 of each 2-week cycle

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00118755 on ClinicalTrials.gov