| Eligibility |
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
- Patient must have an estimated life expectancy >= 4 months in the opinion of the
investigators
- 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, use of an intrauterine device (IUD) or abstinence
- Female patients must have a negative pregnancy test at screening
- Female patients of childbearing potential must agree to use an acceptable method
of birth control (excluding hormonal birth control methods) for 72 hours prior to
admission and to continue its use during the study and for at least 30 days after
the final dose
- Male patients must agree to use an acceptable form of birth control from study
day 1 through at least 30 days after the final dose
- Absolute neutrophil count (ANC) > 1500/mm^3
- Platelet count > 100,000/mm^3
- Serum creatinine < 1.5 mg/dL
- Serum bilirubin count < 1.5 x upper limit normal (ULN)
- Serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamate pyruvate
transaminase (SGPT) < 2.5 x ULN; for subjects with known liver metastases < 5 x ULN
- Karnofsky performance status > 60%
- Signed informed consent form
- Patients are required to read and understand English to comply with protocol
requirements
Exclusion Criteria:
- Any current treatment, medical history, or uncontrolled condition, other than
malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or
psychiatric condition) that, in the opinion of the investigator, would confound the
results of the study or pose any unwarranted risk in administering study drug to the
subject
- Patient has a known hypersensitivity to the administration of any prescribed oral or
intravenous study medication or metabolite, including but not limited to, a history of
hypersensitivity to the drugs or their components, severe renal impairment, severe
bone marrow suppression, or systemic infection
- Patient is a woman with a positive urine or serum pregnancy test within 3 days prior
to study drug administration, is breast-feeding, or is planning to conceive children
within the projected duration of the study treatment
- Patient has taken the anti-emetic agents within the last 48 hours prior to the start
of treatment with study drug:
- 5-hydroxytryptamine (HT)3 antagonists (ondansetron, granisetron, dolasetron,
tropisetron, etc.); palonosetron is not permitted within 7 days prior to
administration of investigational product
- Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine,
chlorpromazine, etc.)
- Benzamides (metoclopramide, alizapride, etc.)
- Domperidone
- Cannabinoids
- Neurokinin (NK)1 antagonist (aprepitant)
- Benzodiazepines (lorazepam, alprazolam, etc)
- Herbal medications or preparations in doses designed to ameliorate nausea or
emesis
- Patient has received systemic corticosteroids or sedative antihistamines
(dimenhydrinate, diphenhydramine, etc.) within 72 hours of day 1 of the study except
as premedication for chemotherapy (e.g., taxanes); subjects who are receiving inhaled
steroids for respiratory conditions or topical steroids for skin disorders can be
enrolled
- Patient has symptomatic primary or metastatic central nervous system (CNS) disease
- Patient has ongoing vomiting, retching, dry heaves, or clinically significant nausea
caused by any etiology, or has had such symptoms within 24 hours prior to the start of
day 1 of the study intervention, or has a history of anticipatory nausea and vomiting
- Patient must not have been dosed with test drug or blinded study drug in another
investigational study within 30 days or 5 half-lives of the biologic activity of the
test drug, whichever is longer, before the time of first study dose
- Patient who is participating in any investigational agent that is not Food and Drug
Administration (FDA)-approved
- 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
- 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
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