Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
SarcomaOral Mucositis
Interventions
DRUG

Palifermin

180 mcg/kg 3 days prior to chemotherapy

DRUG

Placebo

Single dose 3 days prior to chemotherapy

DRUG

Adriamycin (Doxorubicin)

30 mg/m\^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m\^2).

DRUG

Ifosfamide

2.5 g/m\^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m\^2); for patients receiving the AI Regimen.

DRUG

Vincristine

2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen.

DRUG

Cisplatin

120 mg/m\^2 on day 0, for patients receiving the AP Regimen.

Trial Locations (1)

77030

U.T.M.D. Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT00267046 - Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma | Biotech Hunter | Biotech Hunter