A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

August 24, 2026 updated by: Hoffmann-La Roche

A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • PARK Springs, Arizona, United States, 71913
      • Sedona, Arizona, United States, 86336
      • Tucson, Arizona, United States, 85712
    • California
      • Anaheim, California, United States, 92801
      • Colton, California, United States, 92324
      • Greenbrae, California, United States, 94904
      • Loma Linda, California, United States, 92354
      • Modesto, California, United States, 95355
      • Montebello, California, United States, 90640
      • Pomona, California, United States, 91767
      • Sacramento, California, United States, 95816
    • Connecticut
      • Norwich, Connecticut, United States, 06360
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Lake Worth, Florida, United States, 33431
      • Miami Shores, Florida, United States, 33179
      • New Port Richey, Florida, United States, 34655
      • Ocala, Florida, United States, 34474
      • Ocoee, Florida, United States, 34761
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Niles, Illinois, United States, 60714
    • Kentucky
      • Paducah, Kentucky, United States, 42002
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
    • Maryland
      • Baltimore, Maryland, United States, 21204
      • Baltimore, Maryland, United States, 21237
      • Westminster, Maryland, United States, 21157
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
      • Worcester, Massachusetts, United States, 01608
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
    • Minnesota
      • Duluth, Minnesota, United States, 55805
    • Missouri
      • Jefferson City, Missouri, United States, 65109
    • Montana
      • Great Falls, Montana, United States, 59405
    • Nevada
      • Las Vegas, Nevada, United States, 89109
    • New Jersey
      • Neptune City, New Jersey, United States, 07754
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
      • Albuquerque, New Mexico, United States, 87131-5636
      • Santa Fe, New Mexico, United States, 87505
    • New York
      • Brooklyn, New York, United States, 11219
      • Huntington Station, New York, United States, 11746
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Hickory, North Carolina, United States, 28602
    • Ohio
      • Canton, Ohio, United States, 44718
    • Oregon
      • Eugene, Oregon, United States, 97401-8122
    • Pennsylvania
      • Ephrata, Pennsylvania, United States, 17522
      • Langhorne, Pennsylvania, United States, 19047
      • Philadelphia, Pennsylvania, United States, 19102
      • Scranton, Pennsylvania, United States, 18510
    • South Carolina
      • Charleston, South Carolina, United States, 29406
      • Charleston, South Carolina, United States, 29403-5740
      • Florence, South Carolina, United States, 29506
      • Sumter, South Carolina, United States, 29150
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Cookeville, Tennessee, United States, 38501
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Amarillo, Texas, United States, 79106
      • Arlington, Texas, United States, 76014
      • Beaumont, Texas, United States, 77702-1449
      • Bedford, Texas, United States, 76022
      • Carrollton, Texas, United States, 75010
      • Corpus Christi, Texas, United States, 78412
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75237
      • Fort Worth, Texas, United States, 76104
      • Garland, Texas, United States, 75042
      • Lewisville, Texas, United States, 75067
      • Mesquite, Texas, United States, 75150
      • Paris, Texas, United States, 75460
      • Round Rock, Texas, United States, 78681
      • San Antonio, Texas, United States, 78229
      • Southlake, Texas, United States, 76092
      • Sugarland, Texas, United States, 77479
      • Waco, Texas, United States, 76712
      • Webster, Texas, United States, 77598-4420
    • Utah
      • Salt Lake City, Utah, United States, 84106
    • Virginia
      • Christiansburg, Virginia, United States, 24073
    • Washington
      • Seattle, Washington, United States, 98133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients, ≥18 years of age
  • Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
  • ≥1 measurable target lesion
  • Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Exclusion Criteria:

  • Prior systemic therapy for advanced or metastatic disease
  • History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
  • Clinically significant cardiovascular disease
  • Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
  • Chronic daily treatment with >325 mg/day aspirin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XELOX + bevacizumab (Q2W)
Drug: capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
Drug: bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle
Drug: oxaliplatin
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Experimental: XELIRI + bevacizumab (Q2W)
Drug: capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
Drug: bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle
Drug: irinotecan
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) in U.S. Patients Only
Time Frame: From first patient enrolled up to approximately 48 months
PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
From first patient enrolled up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimated)

March 25, 2008

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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