One-hour paclitaxel infusion schedules: a phase I/II comparative trial.
The safety and feasibility of two 1-hour outpatient paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) infusion schedules were evaluated in a randomized phase I/II study of 56 patients with a variety of resistant and refractory advanced cancers. Paclitaxel 135 mg/m2 was infused as a single dose over 1 hour or was divided into three doses infused over 1 hour on 3 consecutive days. Standard paclitaxel premedications were given. The two schedules produced similar toxicity. Total alopecia was universal. Myelosuppression was the most common severe toxicity: 19% and 2%, respectively, of the 162 courses were associated with grades 3 and 4 leukopenia. Neutropenic fever necessitated nine hospitalizations (eight patients.) Preliminary findings show objective responses in 11 patients (20%). Responders had breast, ovarian, and lung cancers. We conclude that both 1-hour paclitaxel outpatient infusion schedules are safe, and we are currently investigating a 200 mg/m2 dose and the incorporation of the 135 mg/m2 schedules into phase II combination chemotherapy regimens.
Greco
F A
FA
Sarah Cannon (Minnie Pearl) Cancer Center, Centennial Medical Center, Nashville, TN 37203, USA.
Hainsworth
J D
JD
D001772:Blood Cell Count; D001943:Breast Neoplasms / Q000188:drug therapy; D002927:Cimetidine / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use; D004155:Diphenhydramine / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D009369:Neoplasms / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011292:Premedication; D012074:Remission Induction
D003907:Dexamethasone; D002927:Cimetidine; D004155:Diphenhydramine; D017239:Paclitaxel