Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)

NACompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
SarcomaNauseaVomiting
Interventions
DRUG

Palonosetron - Single Dose

0.25 mg by vein for 1 dose (day 0).

DRUG

Palonosetron - Triple Dose

0.25 mg by vein for 3 doses (days 0, 2, 4).

DRUG

Adriamycin

75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0.

DRUG

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.

DRUG

Zinecard

750 mg/m2 as an IV bolus.

DRUG

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).

DRUG

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."

DRUG

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.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT00410488 - Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI) | Biotech Hunter | Biotech Hunter