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

Completed · Not applicable

Conditions studied: Sarcoma, Nausea, Vomiting

In brief

The goal of this clinical research study is to compare 2 treatment schedules of Aloxi (palonosetron) in patients with sarcoma who are receiving chemotherapy with adriamycin and ifosfamide. The safety of the drug and schedules will be studied. The effect of palonosetron on patients' quality of life (QOL) will also be studied.

Key facts

Study ID

NCT00410488

Run by

M.D. Anderson Cancer Center

People needed

51

Starts

2006-12-01

Expected to finish

2011-06-01

Last updated by the study team

2013-03-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with sarcoma which is locally advanced, at high risk for relapse or metastatic for whom treatment with AI is indicated.
• Must be between the ages of 18 and 65 years of age.
• Patients with childbearing potential (defined as not post menopausal for 12 months or no previous surgical sterilization) must use adequate birth control.
• Adequate hematologic (Absolute neutrophil count (ANC)>/= 1500/mm\^3, >/= hemoglobin (Hgb, Hb) 10gm/dL, platelet count >/= 150,000/mm\^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 * normal and Serum glutamic pyruvic transaminase (SGPT) <3 * normal) functions.
• Karnofsky Performance Status >/= 80.
• Signed informed consent form.

You may not qualify if…

• Pregnant or lactating women.
• Patients with comorbid condition which renders patients at high risk of treatment complication.
• Patients with symptomatic or untreated metastatic disease to CNS.
• Patients with significant cardiac disease (New York Heart Association (NYHA) Class III or IV), arrhythmia, or recent history of Myocardial infarction (MI) or ischemia.
• Patients with known hypersensitivity to 5-HT3 antagonists.
• Any vomiting or >/= grade 2 nausea in the 24 hours preceding chemotherapy.
• Ongoing vomiting from any organic etiology.
• Radiotherapy within 2 weeks of study entry.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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