51
Participants
Start Date
December 31, 2006
Primary Completion Date
June 30, 2011
Study Completion Date
June 30, 2011
Palonosetron - Single Dose
0.25 mg by vein for 1 dose (day 0).
Palonosetron - Triple Dose
0.25 mg by vein for 3 doses (days 0, 2, 4).
Adriamycin
75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.
Ifosfamide chemotherapy (AI)
Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2). Cycle is 3 weeks, up to 6 cycles.
Zinecard
750 mg/m2 as an IV bolus.
Mesna
500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hour for days 0, 1, 2, and 3 (infusion completing on day 4).
Vincristine
"2 mg IV by rapid administration on day 0 (for patients with small cell histology).~For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 0 only."
Dexamethasone
IV piggyback (IVPB) daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy.
UT MD Anderson Cancer Center, Houston
Eisai Inc.
INDUSTRY
M.D. Anderson Cancer Center
OTHER