Rolapitant Hydrochloride in Preventing Nausea/Vomiting in Patients With Sarcoma Receiving Chemotherapy

PRIMARY OBJECTIVE: I. To evaluate the effect of rolapitant hydrochloride (rolapitant) on nausea/vomiting in patients with sarcoma receiving multi-day highly emetogenic chemotherapy (HEC) regimen of doxorubicin and ifosfamide (AI). SECONDARY OBJECTIVES: I. To evaluate the toxicity of rolapitant in patients receiving AI regimen. II. To evaluate the effects of rolapitant on patient reported outcomes. OUTLINE: PART I: Patients receive dexamethasone intravenously (IV) daily and ondansetron IV on days 1-5, and rolapitant hydrochloride orally (PO) on day 1. PART II: Patients are randomized to 1 of 2 arms. ARM I: Patients receive treatment as in part I. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive dexamethasone IV and ondansetron IV on days 1-5, and fosaprepitant dimeglumine IV over 30 minutes on days 1 of cycle 2. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY: All patients receive doxorubicin IV over 72 hours, mesna IV, and ifosfamide IV over 3 hours on days 1-4 or 1-5. Patients with sarcomas of small cell histology receive vincristine sulfate IV on day 1. Cycles repeat every 3 weeks following blood count and patient recovery from any acute toxicities.