47
Participants
Start Date
May 31, 2012
Primary Completion Date
March 31, 2016
Study Completion Date
March 31, 2016
Fosaprepitant
150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm.
Dexamethasone
Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)
5HT3 receptor antagonist
5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy
Ifosfamide-based chemotherapy (AI)
Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.
Doxorubicin
25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.
Mesna
Prior to ifosfamide (Day 1) - 500 mg/m\^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m\^2. The mesna infusion complete 24 hours after last dose of ifosfamide.
Ifosfamide
2.5 g/m\^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m\^2).
Vincristine
2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
University of Texas MD Anderson Cancer Center, Houston
Merck Sharp & Dohme LLC
INDUSTRY
M.D. Anderson Cancer Center
OTHER