Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

Sarcoma Clinical Trial

Official title: Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 of 2 study groups, each with 2 divisions:

• If you are in Group A1, you will receive fosaprepitant on Day 1 of Cycle 1.

• If you are in Group A2, you will receive fosaprepitant on Day 1 of Cycle 2.

• If you are in Group B1, you will receive fosaprepitant on Days 1 and 4 of Cycle 1.

• If you are in Group B2, you will receive fosaprepitant on Days 1 and 4 Cycle 2.

You and the study staff will know to which group and division you are assigned. Each time you receive the drug, you will receive it by vein over about 20-30 minutes.

You will also receive the ifosfamide-based chemotherapy prescribed by your doctor, as well as standard drugs for preventing nausea and vomiting (such as ondansetron, lorazepam, diphenhydramine, and promethazine). You will sign a separate consent form that will describe these treatments in detail, along with their risks.

You will receive dexamethasone before chemotherapy, every day for 5 days, to help prevent nausea and vomiting.

Before each chemotherapy cycle, you will be given a study diary. Each day, you will record any side effects you may . You should bring your study diary to every study visit so the study staff can review it.

Study Visits:

Before each cycle that you receive fosaprepitant, the following tests and procedures will be performed:

• You will have a physical exam.

• Your vital signs, weight, and performance status will be recorded.

• You will fill out the same questionnaire you did at screening.

• You will be asked about any other drugs you may be taking. Be sure to tell the study doctor about all drugs (including vitamins, herbal products, and nutritional supplements), because some drugs/substances will cause side effects when taken at the same time as fosaprepitant.

• Blood (about 5 teaspoons) will be drawn for routine tests.

Blood (about 1 teaspoon) will also be drawn 2 times each week during Cycles 1 and 2 for routine tests.

Pharmacokinetic Testing:

On Days 1 and 4 of Cycles 1 and 2 of chemotherapy, blood samples (about 2 teaspoons each time) will be drawn for pharmacokinetic (PK) testing, when possible. PK testing measures the amount of study drug in the body at different time points. The blood will be drawn before you receive ifosfamide, at the end of the infusion, and 4 more times in the 24 hours after the infusion.

Length of Study:

You may receive up to 6 cycles of chemotherapy (and up to 5 cycles of fosaprepitant). You will no longer be able to take the study drug if the disease gets worse or if intolerable side effects occur.

Your participation on the study will be over once you have completed the end-of-study visit.

End-of-Study Visit:

About 3 weeks after your last dose of fosaprepitant, you will return for an end-of-study visit. At this visit, the following tests and procedures will be performed:

• You will have a physical exam.

• Your vital signs, weight, and performance status will be recorded.

• You will fill out the same questionnaire you did at screening.

• You will be asked about any other drugs you may be taking.

• Blood (about 5 teaspoons) will be drawn for routine tests.

This is an investigational study. Fosaprepitant is FDA approved and commercially available in combination with other drugs for the prevention of nausea and vomiting that may be caused by chemotherapy. It is investigational to study how fosaprepitant may affect the drug levels of ifosfamide in the blood and how many doses should be given.

Up to 36 patients will take part in this study. All will be enrolled at MD Anderson. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT01490060
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2012