A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

Summary

This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m\^2 orally \[po\] twice a day \[bid\] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil \[5-FU\] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

Conditions

• Colorectal Cancer

Interventions

DRUG

Oxaliplatin 130 mg/m^2

Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.

DRUG

Capecitabine 1000 mg/m^2

Capecitabine was taken within 30 min after the end of breakfast and dinner.

DRUG

Bevacizumab 7.5 mg/kg

Bevacizumab was administered in a 30 to 90 min infusion.

DRUG

Placebo for bevacizumab 7.5 mg/kg

Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.

DRUG

Oxaliplatin 85 mg/m^2

Oxaliplatin 85 mg/m\^2 was administered simultaneously with leucovorin in a 2 h infusion.

DRUG

Leucovorin 200 mg/m^2

Leucovorin was administered simultaneously with oxaliplatin 85 mg/m\^2 in a 2 h infusion.

DRUG

Fluorouracil 400 mg/m^2

DRUG

Bevacizumab 5 mg/kg

Bevacizumab was administered in a 30 to 90 min infusion.

DRUG

Placebo for bevacizumab 5 mg/kg

Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.

Sponsors & Collaborators

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-07-31

Primary Completion

2006-01-31

Completion

2009-04-30

Countries

• United States
• Australia
• Austria
• Brazil
• Canada
• China
• Czechia
• Denmark
• Finland
• France
• Germany
• Guatemala
• Hong Kong
• Hungary
• Ireland
• Israel
• Italy
• Mexico
• New Zealand
• Norway
• Panama
• Portugal
• Puerto Rico
• Russia
• South Africa
• South Korea
• Spain
• Sweden
• Switzerland
• Taiwan
• Thailand
• Turkey (Türkiye)
• United Kingdom

Study Locations