Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting
Inclusion Criteria:
- diagnosis of cancer
- scheduled to receive a chemotherapy treatment containing at least moderately
emetogenic chemotherapy:
- chemotherapy to be given in an inpatient setting
- chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent
- patients may be treatment naive or have been treated previously with chemotherapy
- chemotherapy agents may be given orally, intravenously, or by continuous infusion on
one or multiple days
- scheduled to receive a 5-HT3 receptor antagonist antiemetic: ondansetron,
granisetron, palonosetron or dolasetron mesylate, dexamethasone with or without a
benzodiazepine on the day of treatment according to published antiemetic guidelines
or as clinically indicated
- able to understand English (all assessment instruments are in English)
- 18 years of age or older
- informed consent
- self report of at least mild nausea which the patient feels needs rescuing or
"moderate nausea" (a score of >2 on a 4 point Likert scale) or at least one episode
of emesis since receiving chemotherapy
Exclusion Criteria:
- patients who have received aprepitant as prophylaxis or rescue treatment during the
current cycle of chemotherapy
- patients who are pregnant, have positive serum hCG, or are lactating
- patients with clinical evidence of current or impending bowel obstruction (patients
with tumor pressing on their bowel) or symptomatic brain metastases
- patients receiving a scheduled dopamine antagonist after chemotherapy
- patients with an allergy to or history of intolerance of any of the study drugs will
be excluded from the study
- history of chronic nausea/vomiting without chemotherapy, history of anticipatory
nausea/vomiting, or emesis within 24 hours prior to chemotherapy starting