At a glance
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Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen
In Brief
A clinical study evaluating Fosaprepitant, Dexamethasone, and 6 other interventions for Sarcoma and 3 related conditions. Completed, enrolled 47 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm.
Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)
5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy
Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.
25 mg/m\^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m\^2) as part of AI Chemotherapy.
Prior to ifosfamide (Day 1) - 500 mg/m\^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m\^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m\^2. The mesna infusion complete 24 hours after last dose of ifosfamide.
2.5 g/m\^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m\^2).
2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.