E4805 A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma
To determine the effect of two different doses of AVE0005(VEGF Trap)treatment on the progression-free proportion at 8 weeks in patients with metastatic renal cancer hwo had previous been treated with a tyrosine kinase inhibitor(TKI)
must have histologically confirmed metastatic or resectable renal cell carcinoma with a component of conventional clear cell; must have measurable disease per RECIST; must have evidence of progressive disease following treatment with a TKI; must have received only one prior treatment with either Sutent or Nexavar for at least 12 weeks; prior treatment with Il-2 and interferon alpha is allowed; treatment with TKI must have ended greater than / equal to 1 week prior to starting treatment with VEGF Trap and all toxicities must have resolved;no prior chemo,cellular, vaccine or hormonal therapy is allowed; previous RT is allowed as long as measurable disease is outside the RT port,and must have ended greater than 3weeks prior to randomization; 18 yrs of age or greater than ; ECOG PS 0-2; must have recovered from any toxic effects of prior RT or surgical procedures; adequate organ function;no metastatic CNS disease; females- not pregnant or breastfeeding; sexually active males and women of childbearing potential must agree to use an effective method of contraception while on the study and for 6 months after completion;prior malignancies are ok as long as treatment was for curative intent and are disease free for greater than 5 years; none of the following conditions within 6 months prior to randomization:MI, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, NYHA class II or IV CHF, CVA or TIA; no prior PE, DVT or other thromboembolic event, uncontrolled hypertension, active infection, bleeding disorder.
ARM A- VEGF 4mg/kg IV every 2 weeks until disease progression ARM B- VEGF 1 mb/kg IV every 2 weeks until disaease progression then dose escalated to 4mg/kg IV every 2 weeks until further disease progression
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