Overview

Fosaprepitant in Patients Receiving Ifosfamide-based Regimen

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Aprepitant
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Fosaprepitant
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Mesna
Vincristine
Criteria
Inclusion Criteria:

1. 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.

2. Must be 18-65 years of age.

3. 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.

4. Adequate hematologic (ANC >/= 1500/mm^3, platelet count >/= 100,000/mm^3), renal
(serum creatinine SGOT or SGPT
5. Karnofsky Performance Status >/= 60%

6. Signed informed consent form.

7. Patients are required to read and understand English to comply with protocol
requirements.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Patients with any co-morbid condition which renders patients at high risk of treatment
complication.

3. Known allergy to fosaprepitant or any of its active components.

4. 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.

5. 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).

6. Prior surgery or radiotherapy (RT) within 2 weeks of study entry.

7. Psychological, social, familial, or geographical reasons that would prevent scheduled
visits and follow-up.

8. Patients receiving any medication for pre-existing nausea/vomiting will be excluded.