PHASE-II STUDY OF DOCETAXEL IN PATIENTS WITH EPITHELIAL OVARIAN-CARCINOMA REFRACTORY TO PLATINUM

We analyzed the efficacy and toxicity of docetaxel in patients with ov arian cancer who failed previous chemotherapy with platinum, Fifty-fiv e patients with measurable ovarian cancer were entered in this Phase I I study at The University of Texas M.D. Anderson Cancer Center, Treatm ent consisted of 100 mg/m(2) docetaxel given i.v, every 3 weeks, Becau se of hypersensitivity reactions, premedication with steroids and anti histamine was initiated during the study, Twenty-two (40%) patients re sponded (there were 3 complete responders and 19 partial responders), Twenty-one (38%) patients had stable disease, The median survival was 10 months, The main toxicity was neutropenia (98% of patients), with 1 3 episodes of neutropenic fever, Cumulative fluid retention was the ma in reason for dose modification and required a combination of diuretic s and steroids for palliation, Other side effects were alopecia (100%) ; anemia (87%); dermatitis (67%); gastrointestinal disorders (53%); st omatitis (49%); neurotoxicity (45%); excessive lacrimation (33%); and hypersensitivity reactions (11%), which in one case were life threaten ing (loss of consciousness, fluid resuscitation), Docetaxel as a singl e agent proved to be active in heavily pretreated ovarian cancer patie nts but is associated with significant side effects, Objective toxicit y consisted mainly of neutropenia and fluid retention, Neutropenia was dose limiting and required therapy with granulocyte colony-stimulatin g factor, Fluid retention was improved but not eliminated by diuretics and corticosteroids. Additional studies of docetaxel in ovarian carci noma are indicated to define the activity in relation to paclitaxel an d in platinum combination therapy.