A phase II study single agent of aflibercept (VEGF Trap) in patients with recurrent or metastatic gynecologic carcinosarcomas and uterine leiomyosarcoma. A trial of the Princess Margaret Hospital, Chicago and California Cancer Phase II Consortia

Evaluation of toxicity and tumor response

Baseline evaluations included medical history, physical examination, laboratory tests (hematology, urinalysis, coagulation, blood chemistry), ECG (if indicated), and pregnancy test and were performed within 7 days of administration of protocol therapy. Physical exam, lab tests (hematology, biochemistry and urinalysis), evaluation of toxicity according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3 were performed on day 1 of each cycle. Blood pressure and pulse were measured every cycle with measurements made prior to commencing aflibercept, at 30 minutes into the infusion and 30 minutes post infusion during cycle 1 and 2. Radiologic assessment of measureable disease was performed by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days prior to registration and every 4 cycles (8 weeks). Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST) [23].