Phase II evaluation of docetaxel (D) plus exisulind (E) in patients (pts) with androgen independent prostate carcinoma (AIPC)

4758 Background: Preclinical data suggested synergistic anti-tumor activity with the combination of D + E in AIPC. E is a GMP phosphodiesterase inhibitor administered orally. We designed a trial evaluating tumor response (↓PSA ≥50% lasting ≥4 wks) to D given on a weekly schedule + E daily. Methods: AIPC pts showing progressive disease after anti-androgen withdrawal were enrolled. Up to 2 prior chemotherapy (chemo) regimens were allowed. Planned treatment included 6 cycles of D 35 mg/m2 IV Q wk × 4 followed by 2 wks of rest. E 250 mg PO BID was initiated D 8. The statistical endpoint for this trial was the % of pts with ↓ in PSA ≥50% lasting ≥4 wks. A 2 stage trial was designed where the study would terminate if the % of pts meeting the endpoint was not convincingly >40%. If ≤3/14 pts responded in stage 1, this criterion would be met. During wks 1 and 3 serial plasma samples were obtained (last sample 168h). [D] were measured using a validated LC/MS/MS method and D pharmacokinetic (PK) parameters were dete...