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

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: Colorectal Cancer
• Intervention / Treatment: Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]; Drug: oxaliplatin; Drug: irinotecan

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

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, 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
    • Sugar Land, 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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Clinical Study Report Synopsis

Study record dates

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 (Estimate): March 25, 2008

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Oxaliplatin; Bevacizumab; Irinotecan
• Other Study ID Numbers: ML21567