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Trial information
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer.
Status: Recruiting
Protocol number: ML21567
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
Brief summary: This 2 arm study will 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 will be randomized to receive 2-weekly cycles of treatment with either 1)Xeloda (1000mg/m2 po bid on days 1-7), Avastin (5mg/kg iv on day 1) and oxaliplatin (85mg/m2 on day 1, only in cycles 1-12) or 2)Xeloda (1000mg/m2 po bid on days 1-7), Avastin (5mg/kg iv on day 1) and irinotecan (135mg/m2 on day 1, only in cycles 1-12). After 9 cycles, patients will continue to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is
230.
Study phase: II
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 Time frame: Event driven
Key secondary outcomes: 1. Overall response rate, overall survival, time to response, duration of overall response, time to progression, time to treatment failure, rate of completion of 12 cycles of triple-drug therapy, rate of surgical intervention. Time frame: Event driven
2. Progression-free survival rates Time frame: 6, 9 and 12 months
3. Adverse events, laboratory parameters. Time frame: Throughout study
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 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 >325mg/day aspirin.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2008
Trial registration date: 03/18/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:United States - Park Springs, AZ
- Sedona , AZ
- Tucson , AZ
- Anaheim, CA
- Colton, CA
- Fountain Valley, CA
- Grass Valley, CA
- Greenbrae, CA
- La Verne, CA
- Loma Linda, CA
- Los Angeles, CA
- Mission Hills, CA
- Modesto, CA
- Montebello, CA
- Pomona, CA
- Sacramento, CA
- Norwich, CT
- Waterbury, CT
- West Haven, CT
- Jacksonville, FL
- Lake Worth, FL
- Miami Shores, FL
- New Port Richey , FL
- Ocala, FL
- Ocoee , FL
- Marietta, GA
- Niles, IL
- Skokie, IL
- Lexington, KY
- Paducah, KY
- Alexandria, LA
- Baltimore, MD
- Westminster, MD
- Pittsfield, MA
- Worcester, MA
- Kalamazoo, MI
- Duluth, MN
- Jefferson City, MO
- Great Falls, MT
- Las Vegas, NV
- Reno , NV
- Neptune, NJ
- Albuquerque, NM
- Santa Fe, NM
- Brooklyn, NY
- Huntington Station, NY
- Durham, NC
- Greenville, NC
- Hickory , NC
- Bismarck, ND
- Canton, OH
- Columbus, OH
- Eugene, OR
- Ephrata, PA
- Langhorne, PA
- Media, PA
- Philadelphia, PA
- Pittsburgh, PA
- Scranton, PA
- Charleston, SC
- Columbia, SC
- Florence, SC
- Mount Pleasant, SC
- Sumter, SC
- Chatanooga, TN
- Cookeville, TN
- Nashville, TN
- Abilene, TX
- Amarillo, TX
- Arlington, TX
- Austin, TX
- Beaumont , TX
- Bedford, TX
- Carrollton, TX
- Corpus Christi, TX
- Dallas, TX
- Fort Worth, TX
- Garland, TX
- Lewisville, TX
- Lubbock, TX
- Mesquite, TX
- Paris, TX
- Round Rock , TX
- San Antonio, TX
- Southlake, TX
- Sugarland, TX
- Waco, TX
- Webster, TX
- Salt Lake City, UT
- Christiansburg, VA
- Tacoma, WA
- Walla Walla, WA
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