{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"22.8","value":"4.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"}],"units":"Participants"}],"description":"Response rate (RR) and progression free survival (PFS) were assessed in a 2-stage accrual design (22+18). A maximum of 40 patients were to be accrued to rule out a null hypothesized RR of 4% and PFS of 3 months versus alternative of 15% RR and 5.4 months PFS (corresponding to 4 month PFS of 40% vs 60%) with α=0.12 and β=0.19. If no more than 1 objective response (no more than 4.5%), and no more than 10 instances of 4-month PFS (no more than 45%), were observed among the initial 22 patients, the study would be terminated early and declared negative. Tumor response was evaluated by CT or MRI using RECIST v1.0 criteria.\n\nResponders were confirmed partial or complete responses to treatment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.\n\nziv-aflibercept: Given IV\n\npharmacological study: Correlative studies","id":"OG000","title":"Treatment (Ziv-aflibercept)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From the start of the treatment until disease progression or recurrence, assessed up to 4 years","title":"Tumor Response Rate","type":"PRIMARY","unitOfMeasure":"percentage of responders"}