Phase II study of weekly docetaxel and fixed dose rate gemcitabine in patients with previously treated advanced soft tissue and bone sarcoma

Purpose: The purpose of this prospective multicenter phase II study was to evaluate the efficacy and toxicity of weekly docetaxel and fixed dose rate gemcitabine in patients with previously treated advanced soft tissue and bone sarcoma. Methods: Patients with advanced soft tissue or bone sarcoma, previously treated with ifosfamide and anthracycline-based chemotherapies, were treated with docetaxel (35 mg/m ² over 60 min) and gemcitabine (1,000 mg/m ² over 100 min) on days 1 and 8 of every 3-week cycle. Results: From September 2008 to August 2010, 30 patients were enrolled; 24 (80.0%) were men and median patient age was 45 years (range 17-70 years). The patients received a total of 136 cycles of therapy (median 4 cycles per patient; range 1-15 cycles). Of these 30 patients, none achieved complete response (CR) and 5 achieved a partial response (PR), making the overall response rate 16.7% (95% CI, 2.5-30.8%). Twelve patients had stable disease (SD), resulting in tumor control (CR or PR or SD) in 17 of 30 patients (56.7%). Median progression-free survival was 2.5 months (range 0.8-15.3 months), and median overall survival was 8.4 months (range 1.4-22.3 months). Grade 3 or 4 neutropenia, thrombocytopenia, and anemia were observed in 17 (56.7%), 13 (43.4%), and 4 (13.3%) patients, respectively. None of these patients, however, had febrile neutropenia or bleeding events, and all non-hematologic toxicities were manageable. Conclusions: The combination of weekly docetaxel and fixed dose rate gemcitabine was tolerable and may be an active regimen in patients with previously treated advanced sarcoma.