848 Docetaxel (taxotere) as first line therapy for metastatic or recurrent soft tissue sarcoma (STS): A phase II trial

Abstract

The clinical trials group of the National Cancer Institute of Canada is performing a multi-institutional phase II study of docetaxel in patients (pt) with measurable metastatic or recurrent sts with no prior systemic therapy. The starting dose is 100 mg/m² q 3 weeks with dose reduction for severe toxicities. Premedication includes 20 mg oral (po) dexamethasone (D) at 12 and 6 hours (hr) before, 50 mg diphenhydramine and 50 mg ranitidine both iv 1/2 hr before a 1 hr infusion docetaxel followed by 8 mg D po every 12 hr for 6 doses. To date 22 pt have been entered, 1 is ineligible, 6 are too early for evaluation, 13 are evaluable for response and 15 for toxicity. Two partial responses and 6 stable disease have been reported. There have been 2 deaths on study unrelated to drug toxicity. The most common side effects have been: grade III–IV neutropenia (25/32 courses) with a median nadir of 0.4 × 10⁹/1 granulocytes; five cases of febrile neutropenia and two with severe infection. There have been five hypersensitivity reactions only one severe. Mild-moderate lethargy (10 pt) and edema (5 pt) have also been seen. The median delivered dose intensity is 33.14 mg/m². Because two responses have been documented the trial will continue until 30 evaluable pt have been entered. At the current rate of accrual it is expected that the final response rates and toxicities will be available by the time of presentation.