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

Sponsor
Hoffmann-La Roche
Study ID
NCT00118755
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • capecitabine — DRUG
    850 mg/m\^2 po bid on Days 1-14 of each 3-week cycle
  • Oxaliplatin — DRUG
    130 mg/m\^2 IV on Day 1 of each 3-week cycle
  • bevacizumab — DRUG
    7.5 mg/kg IV on Day 1 of each 3-week cycle
  • capecitabine — DRUG
    1500 mg/m\^2 po bid on Days 1-7 of each 2-week cycle
  • Oxaliplatin — DRUG
    85 mg/m\^2 IV on Day 1 of each 2-week cycle
  • bevacizumab — DRUG
    5 mg/kg IV on Day 1 of each 2-week cycle

Study Details

This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m\^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m\^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m\^2 po bid on Days 1-7, oxaliplatin 85 mg/m\^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Key Dates

First listed
Jul 12, 2005
Start date
Jul 31, 2005
Status verified
Feb 2011
Primary completion
Apr 30, 2009

Study Design

Enrollment
435 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Time to disease progression or death (through follow-up phase) ]

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