A phase II, pharmacokinetic (PK), and pharmacodynamic (PD) study of weekly docetaxel (DOC) in patients with platinum-resistant ovarian cancer

e16531 Background: DOC at 30 mg/m2 q wk for 3 wks q 4 wks was modestly active and minimized toxicity in patients (pts) with platinum resistant epithelial ovarian cancer compared to historical data of DOC at 75 to100 mg/m2 q 21 days (Berkenblit, Gynecologic Oncology 2004). However, the optimal schedule of weekly DOC in pts with ovarian cancer has not been determined. Our study assessed the activity and safety of weekly DOC at 36 mg/m2 q wk for 6 wks q 8 wks in platinum and paclitaxel resistant ovarian cancer. PK and PD studies of DOC were performed on wks 1 and 6. Methods: Pts (n = 25) with platinum and paclitaxel resistant ovarian cancer with up to 3 previous treatments were eligible. DOC was administered at 36 mg/m2 IV over 30 min q wk for 6 wks repeated q 8 wks until complete response or disease progression. Plasma samples were obtained from 0 to 24 h after administration of DOC on wks 1 and 6 of cycle 1. DOC plasma conc were determined by liquid chromatography mass spectrometry (LC-MS). Non-compartment...