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Trial information
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
Status: No longer recruiting
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 430.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
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: 08/31/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:United States - Phoenix, AZ
- Sedona , AZ
- Tucson , AZ
- Anaheim, CA
- Campbell, CA
- Loma Linda, CA
- Los Angeles, CA
- Modesto, CA
- Orange, CA
- Soquel, CA
- Vallejo, CA
- Waterbury, CT
- Newark, DE
- Washington, DC
- Boynton Beach, FL
- Brooksville, FL
- Jacksonville, FL
- Lakeland, FL
- New Port Richey , FL
- North Miami Beach , FL
- Ocoee , FL
- Vero Beach, FL
- Atlanta, GA
- Lawrenceville, GA
- Chicago, IL
- Niles, IL
- Peoria, IL
- Skokie, IL
- Indianapolis , IN
- South Bend, IN
- Lexington, KY
- Metairie, LA
- Baltimore, MD
- Columbia, MD
- Pittsfield, MA
- Worcester, MA
- Duluth, MN
- Robbinsdale, MN
- Columbia , MO
- Omaha, NE
- Las Vegas, NV
- Reno , NV
- Manasquan, NJ
- Albuquerque, NM
- Santa Fe, NM
- Albany, NY
- Armonk, NY
- Brooklyn, NY
- Great Neck, NY
- Huntington Station, NY
- Rochester, NY
- South Bronx, NY
- Charlotte, NC
- Durham, NC
- Greenville, NC
- Hickory , NC
- Wilmington, NC
- Cincinnati, OH
- Columbus, OH
- Dayton, OH
- Kettering , OH
- Darby, PA
- Dunmore, PA
- East Stroudsburg, PA
- Ephrata, PA
- Media, PA
- Philadelphia, PA
- Pittsburgh, PA
- Scranton, PA
- 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
- 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
- Colchester, VT
- Salem, VA
- Burien, WA
- Edmonds, WA
- Seattle, WA
- Milwaukee, WI
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