Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

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.

Conditions

• Sarcoma
• Chemotherapy-induced Nausea and Vomiting
• Effects of Chemotherapy
• Adverse Effects of Medical Drugs

Interventions

DRUG

Fosaprepitant

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.

DRUG

Dexamethasone

Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)

DRUG

5HT3 receptor antagonist

5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy

DRUG

Ifosfamide-based chemotherapy (AI)

Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.

DRUG

Doxorubicin

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.

DRUG

Mesna

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.

DRUG

Ifosfamide

2.5 g/m\^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m\^2).

DRUG

Vincristine

2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

Principal Investigators

• Saroj Vadhan-Raj, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-05-31

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• United States

Study Locations