Phase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC)

4657 Background: DHA-paclitaxel (Taxoprexin) is a covalent conjugate of paclitaxel and docosahexaenoic acid that has greater tumor specificity in pre-clinical models than paclitaxel. The conjugate accumulates in tumor tissue where it is cleaved to paclitaxel. The objective of this multi-center study was to evaluate the efficacy and tolerability of TXP as first line therapy in patients with HRPC. Methods: Thirty-six patients, median age 70y (range 56–86) PS 0 (12), PS 1 (24) with advanced HRPC and no previous cytotoxic treatment were enrolled. Patients were required to have adequate renal, hepatic and bone marrow function and measurable disease. TXP was administered iv over 2 hours q21 days at one of two doses, 1100 mg/m2 (14), 900 mg/m2 (22) . Results: Fifty-one courses (mean 3.6) were administered at 1100 mg/m2 and 65 courses (mean 2.9) at 900 mg/m2. Neutropenia was the primary toxicity and was dose limiting: 12 of 14 (86%) patients treated at 1100 mg/m2 had grade 3/4 neutropenia vs. 9 of 22 (41%) at 900...