Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

Completed · Not applicable

Conditions studied: Sarcoma, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy, Adverse Effects of Medical Drugs

In brief

The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied. Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.

Key facts

Study ID

NCT01490060

Run by

M.D. Anderson Cancer Center

People needed

47

Starts

2012-05-01

Expected to finish

2016-03-01

Last updated by the study team

2016-04-11

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 doxorubicin plus ifosfamide (AI) or AI and vincristine (VAI) is indicated.
• Must be 18-65 years of age.
• Male and Females of child bearing potential must use acceptable methods of birth control which include oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, us of a intrauterine device (IUD) or abstinence.
• Adequate hematologic (ANC >/= 1500/mm\^3, platelet count >/= 100,000/mm\^3), renal (serum creatinine </= 1.5 mg/dL), hepatic (serum bilirubin count </= 1.5 x normal and SGOT or SGPT </= 3 x normal) functions.
• Karnofsky Performance Status >/= 60%
• Signed informed consent form.
• Patients are required to read and understand English to comply with protocol requirements.

You may not qualify if…

• Pregnant or lactating women.
• Patients with any co-morbid condition which renders patients at high risk of treatment complication.
• Known allergy to fosaprepitant or any of its active components.
• Patient has uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%), uncontrolled cardiac arrhythmia or hypertension, or acute myocardial infarction within 3 months.
• Patient has an active seizure disorder. (Patients with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and they have been free of antiseizure medication for the previous 5 years).
• Prior surgery or radiotherapy (RT) within 2 weeks of study entry.
• Psychological, social, familial, or geographical reasons that would prevent scheduled visits and follow-up.
• Patients receiving any medication for pre-existing nausea/vomiting will be excluded.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.