This phase II trial is studying how well VEGF Trap works in treating patients with previously treated metastatic colorectal cancer. VEGF Trap may stop the growth of colorectal cancer by blocking blood flow to the tumor.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Given intravenously
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Time frame: Up to 6 years
Progression-free Survival (Bevacizumab- naïve Group)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)
Time frame: 4 months
Progression-free Survival (Bevacizumab-treated Group)
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)
Time frame: 4 months
Overall Survival (Bevacizumab-naïve Group)
Kaplan-Meier method will be used. (Bevacizumab- naïve Group)
Time frame: 12 months
Overall Survival (Prior Bevacizumab Treated Group)
Kaplan-Meier method will be used (Bevacizumab-naïve Group)
Time frame: 12 months
Time to Progression
Kaplan-Meier method will be used.
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Time frame: 12 months
Objective Stable Disease Rate
Time frame: Up to 6 years
Number of Participants With Response (Bevacizumab-naïve Group)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Stable disease for atleast 16 weeks
Time frame: Up to 6 years
Overall Survival (Bevacizumab-treated Group)
Kaplan-Meier method will be used. (Bevacizumab-treated Group)
Time frame: 6 months
Overall Survival (Bevacizumab-treated Group)
Kaplan-Meier method will be used (Bevacizumab-treated Group)
Time frame: 12 months
Number of Participants With Response (Bevacizumab-treated Group)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Stable disease for atleast 16 weeks
Time frame: Up to 6 years