Phase II trial of bevacizumab (A), lenalidomide (R), docetaxel (D), and prednisone (P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

138 Background: Angiogenesis appears to play critical role in the progression of mCRPC. Previously we have shown anti-tumor activity in mCRPC with the combination of D, thalidomide (T), A and P (Ning JCO 2010). We hypothesized that combining R, an analogue of T, with A, D and P would have a more favorable toxicity profile and similar anti-tumor activity. Methods: All pts had chemotherapy-naive progressive mCRPC. 6 pts were treated with R at 15 and 20 mg prior to doses at 25 mg. Treatment is 75 mg/m2 D, 15 mg/kg A every 21 days as one cycle (C), plus 25 mg R for 14 days with daily 10 mg P and enoxaparin. After grade 3 neutropenia was seen in > 80% of pts in all cohorts, the protocol was amended to include prophylactic pegfilgrastim. PSA is tested each C with imaging after C2 and then every 3C. Dental exams with mandible CT's are at baseline, after C5, and then every 6C or earlier if needed. Results: 28 of a planned 51 pts have been enrolled. Pt characteristics include: median age 65.5 [51-78], Gleason scor...