ECOG4805: A Randomized Phase II Study to Determine the Effect of 2 Different
Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma
||Ilan Shapira, MD
| Time frame of study:
|Location of Study:
Beth Israel Medical Center
Continuum Cancer Research Program
In this study, we will try to determine the effectiveness of treatment with VEGF (Vascular endothelial growth factor) Trap, when given in two different doses. There will be two randomized study groups: one group will receive VEGF Trap treatment at a dosage of 4 mg/kg while the other will receive 1 mg/kg. VEGF Trap will be administered to each patient intravenously (through the vein) once every 14 days. Every 8 weeks, the tumor will be assessed and the group which was originally given 1 mg/kg of treatment will start receiving 4 mg/kg. The purpose of this study is to determine if the change in dosage has any beneficial effects on patients diagnosed with metastatic renal cell carcinoma who have been previously treated with TKI (tyrosine kinase inhibitor).
- Must be at least 18 years old.
- Must have histologically confirmed metastatic or renal cell carcinoma that cannot be removed by surgery. Disease must be conventional clear cell carcinoma or have a component of clear cell carcinoma.
- Previous radiation therapy must have been completed > 2 weeks prior to randomization and the patient must have recovered from any acute toxicities associated with radiation therapy
- No collecting duct or medullary carcinoma
- No prior systemic therapy for metastatic disease
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