A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Chinese Patients With Metastatic Colorectal Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT00642577
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab [Avastin] — DRUG
    5mg/kg iv every 2 weeks
  • irinotecan — DRUG
    125mg/m2 iv weekly for 4 weeks of each 6 week cycle
  • leucovorin — DRUG
    20mg/m2 iv weekly for 4 weeks of each 6 week cycle
  • fluorouracil — DRUG
    500mg/m2 iv weekly for 4 weeks of each 6 week cycle

Study Details

This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.

Key Dates

Start date
Jul 31, 2007
Status verified
Dec 2022
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

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

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Progression-free survival. [ Time Frame: 6 months ]

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