Clinical Trial Protocol Registry

Trial information

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

Status:
Completed
Protocol number:
ML18491
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A randomized, open-label study of the effect of 2 different treatment schedules of Xeloda with Eloxatin and Avastin on progression-free survival in treatment-naïve patients with locally advanced or metastatic colorectal cancer
Brief summary:
This 2 arm study will evaluate the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous Eloxatin (oxaliplatin) and intravenous bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients will be randomized to receive either 1)Xeloda 850mg/m2 po bid on days 1-14, oxaliplatin 130mg/m2 iv on day 1, and Avastin 7.5mg/kg iv on day 1 of each 3 week cycle or 2)Xeloda 1500mg/m2 po bid on days 1-7, oxaliplatin 85mg/m2 iv on day 1 and Avastin 5mg/kg iv on day 1 of each 2 week cycle. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 435.
Study phase:
II
Study type:
Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/efficacy study
Conditions:
  • Colorectal Cancer
Primary outcome:
  1. Progression-free survival or death Time frame: Event driven
Key secondary outcomes:
  1. Overall response rate, survival time, duration of response, time to treatment failure, rate of complete surgical resection. Time frame: Event driven
  2. QoL, AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
  • adult patients >=18 years of age;
  • metastatic or inoperable locally advanced colorectal cancer;
  • >=1 measurable target lesion.
Exclusion criteria:
  • previous systemic therapy for advanced or metastatic disease;
  • previous treatment with bevacizumab.
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
July, 2005
Trial registration date:
17.10.2005
Date last updated:
10.06.2013
This trial was conducted at the following locations:
U.S.A.
  • PHOENIX, AZ
  • SEDONA, AZ
  • TUCSON, AZ
  • ANAHEIM, CA
  • BERKELEY, CA
  • BEVERLY HILLS, CA
  • CAMPBELL, CA
  • CORONA, CA
  • LOMA LINDA, CA
  • LOS ANGELES, CA
  • MODESTO, CA
  • ORANGE, CA
  • SOQUEL, CA
  • VALLEJO, CA
  • FAIRFIELD, CT
  • NEW HAVEN, CT
  • TORRINGTON, CT
  • WATERBURY, CT
  • WASHINGTON, DC
  • NEWARK, DE
  • BOYNTON BEACH, FL
  • BROOKSVILLE, FL
  • FORT LAUDERDALE, FL
  • GAINESVILLE, FL
  • JACKSONVILLE, FL
  • LAKE CITY, FL
  • LAKELAND, FL
  • NEW PORT RICHEY, FL
  • NORTH MIAMI BEACH, FL
  • OCOEE, FL
  • TAMPA, FL
  • VERO BEACH, FL
  • ATHENS, GA
  • ATLANTA, GA
  • LAWRENCEVILLE, GA
  • BETTENDORF, IA
  • CHICAGO, IL
  • DEKALB, IL
  • ELMHURST, IL
  • JOLIET, IL
  • NILES, IL
  • PEORIA, IL
  • SKOKIE, IL
  • INDIANAPOLIS, IN
  • SOUTH BEND, IN
  • LEXINGTON, KY
  • METAIRIE, LA
  • PITTSFIELD, MA
  • WORCESTER, MA
  • BALTIMORE, MD
  • COLUMBIA, MD
  • BANGOR, ME
  • DULUTH, MN
  • ROBBINSDALE, MN
  • COLUMBIA, MO
  • ST JOSEPH, MO
  • GREAT FALLS, MT
  • CHARLOTTE, NC
  • DURHAM, NC
  • GREENVILLE, NC
  • HICKORY, NC
  • WILMINGTON, NC
  • FARGO, ND
  • OMAHA, NE
  • PORTSMOUTH, NH
  • MANASQUAN, NJ
  • SOMERSET, NJ
  • SUMMIT, NJ
  • ALBUQUERQUE, NM
  • SANTA FE, NM
  • LAS VEGAS, NV
  • RENO, NV
  • ALBANY, NY
  • ARMONK, NY
  • BRONX, NY
  • BROOKLYN, NY
  • GREAT NECK, NY
  • HUNTINGTON STATION, NY
  • ROCHESTER, NY
  • CINCINNATI, OH
  • COLUMBUS, OH
  • DAYTON, OH
  • KETTERING, OH
  • TOLEDO, OH
  • DARBY, PA
  • DUNMORE, PA
  • EAST STROUDSBURG, PA
  • EPHRATA, PA
  • MEDIA, PA
  • PHILADELPHIA, PA
  • PITTSBURGH, PA
  • SCRANTON, PA
  • UPLAND, PA
  • BEAUFORT, SC
  • CHARLESTON, SC
  • COLUMBIA, SC
  • FLORENCE, SC
  • BRISTOL, TN
  • CHATTANOOGA, TN
  • COOKEVILLE, TN
  • NASHVILLE, TN
  • ABILENE, TX
  • AMARILLO, TX
  • ARLINGTON, TX
  • AUSTIN, TX
  • BEDFORD, TX
  • DALLAS, TX
  • DENTON, TX
  • EL PASO, TX
  • FORT WORTH, TX
  • GARLAND, TX
  • HOUSTON, TX
  • LEWISVILLE, TX
  • LONGVIEW, TX
  • LUBBOCK, TX
  • MCALLEN, TX
  • MESQUITE, TX
  • MIDLAND, TX
  • ODESSA, TX
  • PARIS, TX
  • RICHARDSON, TX
  • SAN ANTONIO, TX
  • SHERMAN, TX
  • SUGARLAND, TX
  • WACO, TX
  • WEBSTER, TX
  • SALT LAKE CITY, UT
  • SALEM, VA
  • COLCHESTER, VT
  • BURIEN, WA
  • EDMONDS, WA
  • SEATTLE, WA
  • MILWAUKEE, WI
  • RACINE, WI
  • MORGANTOWN, WV

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