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

ClinicalTrials.gov ID: NCT00069095

Public ClinicalTrials.gov record NCT00069095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 4:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX-4") With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT00069095
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 2,035 participants

Conditions and interventions

Conditions

Colorectal Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 30, 2003
Primary completion: Dec 31, 2005
Completion: Mar 31, 2009
Last update posted: Oct 5, 2016

2003 – 2009

United States locations

U.S. sites: 49
U.S. states: 24
U.S. cities: 47

Facility	City	State	ZIP	Site status
Not listed	Berkeley	California	94704	—
Not listed	Fountain Valley	California	92708	—
Not listed	Fullerton	California	92835	—
Not listed	Gilroy	California	95020	—
Not listed	Greenbrae	California	94904	—
Not listed	Los Angeles	California	90057	—
Not listed	Orange	California	92868	—
Not listed	Palo Alto	California	94304	—
Not listed	San Diego	California	92123	—
Not listed	Norwich	Connecticut	06360	—
Not listed	Waterbury	Connecticut	06708	—
Not listed	Boca Raton	Florida	33486	—
Not listed	Gainesville	Florida	33610-0277	—
Not listed	Jacksonville	Florida	32207	—
Not listed	New Port Richey	Florida	34652	—
Not listed	Tampa	Florida	33607	—
Not listed	Tampa	Florida	33647	—
Not listed	Atlanta	Georgia	30341	—
Not listed	Chicago	Illinois	60640	—
Not listed	Elk Grove Village	Illinois	60007	—
Not listed	Peoria	Illinois	61615-7828	—
Not listed	Lexington	Kentucky	40536-0098	—
Not listed	New Orleans	Louisiana	70121	—
Not listed	Scarborough	Maine	04074	—
Not listed	Boston	Massachusetts	02135	—
Not listed	Ann Arbor	Michigan	48106	—
Not listed	Saint Louis Park	Minnesota	55416	—
Not listed	Las Vegas	Nevada	89106	—
Not listed	East Orange	New Jersey	07019	—
Not listed	Hamilton	New Jersey	08690	—
Not listed	New Brunswick	New Jersey	08901	—
Not listed	Albuquerque	New Mexico	87131-0001	—
Not listed	Farmington	New Mexico	87401	—
Not listed	New York	New York	10065	—
Not listed	Rochester	New York	14623	—
Not listed	Syracuse	New York	13210	—
Not listed	Charlotte	North Carolina	28203	—
Not listed	Charlotte	North Carolina	28233-3549	—
Not listed	Bismarck	North Dakota	58501	—
Not listed	Fargo	North Dakota	58122	—
Not listed	Sayre	Pennsylvania	18840	—
Not listed	Upland	Pennsylvania	19013	—
Not listed	Providence	Rhode Island	02906	—
Not listed	Charleston	South Carolina	29425	—
Not listed	Columbia	South Carolina	29209	—
Not listed	Memphis	Tennessee	38120	—
Not listed	Houston	Texas	77024	—
Not listed	Burlington	Vermont	05401	—
Not listed	Richmond	Virginia	23294	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 187 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00069095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 5, 2016 · Synced Sep 7, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00069095 live on ClinicalTrials.gov.

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