Phase II Trial of VEGF Trap in Patients With Previously Treated Metastatic Colorectal Cancer
PRIMARY OBJECTIVES:
I. Determine the response rate (complete and partial) in patients with previously treated
metastatic colorectal cancer treated with VEGF Trap.
II. Determine the incidence of disease stabilization, in terms of 4-month progression-free
survival, in patients treated with this drug.
SECONDARY OBJECTIVES:
I. Determine the median survival time of patients treated with this drug. II. Determine the
1-year survival rate and stable disease rate in patients treated with this drug.
III. Determine the response or stable disease duration in patients treated with this drug.
IV. Determine the toxicity of this drug in these patients. V. Determine the time to disease
progression in patients treated with this drug.
VI. Determine if changes in free VEGF Trap levels correlate with response or toxicity.
OUTLINE: This is a multicenter, open-label study.
Patients are stratified according to prior bevacizumab treatment (yes vs no). Patients
receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of
disease progression or unacceptable toxicity. Patients undergo blood collection at the
beginning of each course and at 60 days after completion of study treatment. Samples are
analyzed by immunoenzyme techniques to determine the pharmacokinetics of VEGF Trap.
After completion of study treatment, patients are followed at 30 and 60 days and then every
3 months thereafter.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response (defined as partial or complete response as defined by the RECIST criteria)
Up to 6 years
No
Malcolm Moore
Principal Investigator
University Health Network-Princess Margaret Hospital
United States: Food and Drug Administration
NCI-2009-00176
NCT00407654
October 2006
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