Paclitaxel injectable emulsion: Phase 2a study of weekly administration in patients with platinum-resistant ovarian cancer

Abstract

5047 Background: Paclitaxel Injectable Emulsion (PIE; TOCOSOL Paclitaxel) is a convenient, ready-to-use, Cremophor-free, unmodified paclitaxel product administered over 15 minutes. Methods: As part of a Phase 2A program, a multicenter study of PIE was conducted in taxane-naive patients (pts) with Stage III/IV platinum-resistant ovarian cancer (ov ca) pts receiving 2nd line therapy. Pts were either refractory to induction chemotherapy or had recurrent disease within 6 months of 1st line therapy. PIE was given IV over 15 min weekly. Dose cohorts were 80, 100, and 120 mg/m2. Results: 52 women, median age = 52 yrs, median ECOG PS = 1, 30/21 Stage III/IV were enrolled (one Stage I pt is included in safety but not efficacy analysis). Prior chemo: platinum in all pts, with cyclophosphamide in 49 pts (plus doxorubicin in 10) or gemcitabine in 3. By study design, 7 pts received 80, 6 received 100, and 39 received 120 mg/m2/wk. Accrual is complete; 5 pts are still on therapy; 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%), peripheral neuropathy (G3 9%; G4 0%) and dyspnea (G3 4%; G4 1%). . Infusion-related symptoms were infrequent and generally resolved without treatment if the infusion was interrupted for several minutes. In the ov ca study, pts received PIE for 1 to 47 (median 9) weeks. PIE was discontinued for adverse events in 5 pts, investigator decision in 6, unspecified reasons in 13, and progressive disease in 23 pts. Objective responses by RECIST are summarized in the table. Conclusion: PIE is well tolerated and shows promising efficacy given on a weekly schedule by 15 minute infusion in pts with refractory or resistant ov ca who have progressed after platinum-based therapy. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration PSI Pharma Support Intl; Sonus Pharmaceuticals Sonus Pharmaceuticals Sonus Pharmaceuticals Sonus Pharmaceuticals