N/A
Completed N=47
Fosaprepitant in Patients Receiving Ifosfamide-based Regimen
sarcoma · Chemotherapy-Induced Nausea and Vomiting · Effects of Chemotherapy · Adverse Effects of Medical Drugs
Source: ClinicalTrials.gov NCT01490060 ↗
Enrolled (actual)
47
Serious AEs
7.9%
Results posted
Jun 2015
Primary outcomePrimary: Complete Response — 17; 10; 50 percentage of participants
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response |
17; 10; 50 | — |
Eligibility Criteria
Inclusion Criteria
- 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 /= 60%
- Signed informed consent form.
- Patients are required to read and understand English to comply with protocol requirements.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01490060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.