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Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

Phase 1/Phase 2
18 Years
Not Enrolling
Breakthrough Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting



- To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with
breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic
antiemetic therapy.


- To evaluate toxicity and serious adverse events associated with this regimen in these

- To evaluate the ability of patients to tolerate oral intake.

- To evaluate the health-related quality of life of patients treated with this regimen.

- To evaluate specific side effects associated with this regimen, including pain
sensation and/or soreness at the infusion site, headache, dizziness, and somnolence, in
these patients .

- To refine the study design for future phase II and III studies of rescue therapy for
breakthrough CINV using various secondary endpoints.

OUTLINE: Patients receive chemotherapy in combination with a pre-defined standard 5-HT3
antagonist or corticosteroid regimen with or without a benzodiazepine on day 1. If
breakthrough nausea or vomiting occurs, patients then receive fosaprepitant dimeglumine IV
once per standard administration guidelines. Patients with treatment response may receive
additional doses of oral aprepitant once on days 2 and 3. Patients with persistent
nausea/vomiting after 2 hours and who desire further treatment may receive standard rescue
therapy with prochlorperazine, metoclopramide, or haloperidol with or without additional
lorazepam until relief, at the discretion of the provider.

Patients complete a diary at baseline, and then at 2, 12, and 24 hours that includes a
Visual Analogue Scale (VAS) for nausea; VAS for sedation; and questions about emesis and
retching frequency, headache, dizziness, somnolence, and ability to take food and liquids
orally. Patients also complete the Functional Living Index-Emesis Quality of Life survey at
baseline and at 24 hours.

Inclusion Criteria


- Diagnosis of cancer

- Scheduled to receive inpatient chemotherapy containing at least moderately emetogenic

- May be given for adjuvant, neoadjuvant, curative, or palliative intent

- May be given orally, IV, or by continuous infusion on ≥ 1 day

- Scheduled to receive 5-HT3 receptor antagonist antiemetic (e.g., ondansetron,
granisetron, palonosetron, dolasetron mesylate, or dexamethasone with or without a
benzodiazepine) on the day of chemotherapy

- Self-report of at least mild nausea (for which the patient feels needs rescuing) or
moderate nausea (a score of ≥ 2 on a 4-point Likert scale) OR has had ≥ 1 episode of
emesis since receiving chemotherapy

- No history of chronic nausea and/or vomiting (without chemotherapy), anticipatory
nausea and/or vomiting, or emesis within 24 hours before chemotherapy

- No symptomatic brain metastases


- Able to understand English

- Not pregnant or nursing

- Negative pregnancy test

- No clinical evidence of current or impending bowel obstruction (i.e., tumor pressing
on the bowel)

- No allergy or intolerance to study drugs


- See Disease Characteristics

- Prior chemotherapy allowed

- No aprepitant as prophylaxis or rescue treatment during the current course of
chemotherapy (other than as a part of study therapy)

- Not scheduled to receive a dopamine antagonist after chemotherapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Improvement in nausea score from baseline to 2 hours as assessed by the numerical Visual Analogue Scale

Outcome Time Frame:

Baseline to 2 hours after study drug administered.

Safety Issue:


Principal Investigator

Joseph Bubalo, PharmD, BCPS, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

February 2013

Related Keywords:

  • Breakthrough Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • Nausea
  • Vomiting



Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098