Status:
COMPLETED
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Sarcoma
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 fosapr...
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, you will receive fosaprepitant during 21-day chemotherapy cycles. You will be randomly assigned (as in a toss of dice) to 1 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01490060
Start Date
May 1 2012
End Date
March 1 2016
Last Update
April 11 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-3722