507 A phase II study of taxol® (T) (paclitaxel) over 3 hours (H) in 192 platinum pretreated patients (PTS) for ovarian carcinoma (OC)

Eligibility criteria histologically proven OC, measurable/evaluable disease, relapse/progression after at least one platinum based CT, ≤ 3 prior CT. Treatment 1 or 2 prior CT, T = 175 mg/m2 [Group A (A) = 151 pts]; 3 prior CT, T = 135 mg/m2 [Group B (B) = 41 pts] both by 3 hour IV infusion q 3 w. pts(192): median (med) age: 57 yrs (25–72); PS 0 = 74 pts, PS 1 = 88 pts, PS 2 = 34 pts. nb prior CT: 1 = 81 pts, 2 = 73 pts, 3 = 36 pts. Toxicity (% cycles): 1184 evaluable cycles (cy) (983 in A, 201 in B) with a med nb per pt of 6 in A (1–21), 5 in B (1–11). Cardiac tox.: bradycardia: (≤ 60 bpm) always asymptomatic = 13% (63 pts), hypotension (≤ 90 mm/Hg) = 3% (24 pts), drop in systolic blood pressure 30 mm/Hg = 3% (23 pts). Out of 841 cy EKG 3% were abnormal (13 pts). Minor hypersensitivity reactions (HSR): 18% (A = 19%, B = 9%) in 73 pts, flushing (12%) and skin rash (4%). In 80 cy (7%) symptomatic treatment was required but never T discontinuation. No severe HSR occurred. Hematologic tox. induced treatment delay in 4% (A = 3%, B = 6%) and dose reduction in 1%. Gr 3–4 neutropenia: A = 32%; B = 22%. Eleven pts experienced in 18 cy. any degree off ever of infection associated with a Gr 4 neutropenia, all in A. Thrombocytopenia Gr 3–4 = 1% (10 cy). Anemia Gr 3–4 = 3%, Creatininemia Gr 3 = 1 pt. Liver Tox. = 11 pts (6 with liver metastasis): ALP Gr 3–4 = 1%; ASAT Gr 3 = 0.3%. Nausea/vomiting Gr 1–2 = 13%.; Gr 3 = 2 cy. Mucositis Gr 1–2 = 4% all in A. Paresthesias (present in 45 pts at inclusion) Gr 1–2: A = 43%, B = 28%, Gr 3: A = 5 cy. Myalgias/arthralgias Gr 1–2 =18% (A = 20%, B = 7%) and Gr 3 in 3 cy. Fatique Gr 1–2 = 26%. Edema Gr. 1–2 = 6% and Gr 3 in I cy. No toxic death occurred. Efficacy 185 evaluable pts, RR = 20% (CR = 5%, PR = 15%), SO = 32% (3 pts pCR) Conclusion Taxol® given by 3 H infusion, is well tolerated. The RR seems not different from those observed with 24 H infusion.