Paclitaxel injectable emulsion: phase 2a study of weekly administration in patients with metastatic or locally advanced unresectable or recurrent urothelial transitional cell cancer (TCC)

4586 Background: Paclitaxel Injectable Emulsion (PIE; TOCOSOL™ Paclitaxel) is a convenient, ready-to-use, Cremophor®-free unmodified paclitaxel product administered over 15 min. Methods: As part of a Phase 2A program, a multicenter study of second line PIE was performed in taxane-naive patients (pts) with metastatic or locally advanced, unresectable or recurrent TCC who progressed after cisplatin (cis)-based therapy. PIE was given IV over 15 min weekly to dose cohorts of 80, 100, and 120 mg/m2. Results: 27 pts were enrolled: median age = 65 yrs; 26/1 M/F; median ECOG PS=1; 3 Stage II, 16 Stage III, and 8 Stage IV (6 M1). Prior chemo: cis alone, 11 pts; MVAC or cis/gemcitabine, 12; cis + another agent, 4 pts. By study design, 6 pts received 80, 15, 100 and 6, 120 mg/m2/wk. Therapy is complete; follow-up for progression and survival continues. Grade 3–4 toxicities in more than 5% of pts across the entire Phase 2A program (n=145) included neutropenia (G3 17%; G4 16%; febrile 2%), anemia (G3 11%; G4 1%), peri...