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Fosaprepitant for Breakthrough Chemotherapy Induced Nausea and Vomiting
This study is not yet open for participant recruitment.
Verified by Oregon Health and Science University, July 2009
First Received: July 13, 2009   No Changes Posted
Sponsors and Collaborators: Oregon Health and Science University
Merck
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00939302
  Purpose

The purpose of this study is to test the safety and effectiveness of fosaprepitant. The investigators want to find out what effects, good and/or bad, it has on chemotherapy induced nausea and vomiting that occurs despite the best nausea prevention measures.


Condition Intervention Phase
Breakthrough Chemotherapy Induced Nausea and Vomiting
Drug: fosaprepitant
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fosaprepitant: Experimental Drug: fosaprepitant
150 mg IV once at time of subject breakthrough CINV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939302

Contacts
Contact: Joseph Bubalo, PharmD 503-494-1054 bubaloj@ohsu.edu
Contact: Richard T Maziarz, MD 503-494-1551 maziarzr@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Merck
Investigators
Principal Investigator: Joseph Bubalo, PharmD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Oregon Health & Science University ( Joseph Bubalo, PharmD )
Study ID Numbers: HEM-08053-L
Study First Received: July 13, 2009
Last Updated: July 13, 2009
ClinicalTrials.gov Identifier: NCT00939302     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
breakthrough CINV
fosaprepitant

Study placed in the following topic categories:
Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Antiemetics
Nausea
Peripheral Nervous System Agents
Aprepitant

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Pharmacologic Actions
Signs and Symptoms
Autonomic Agents
Therapeutic Uses
Nausea
Peripheral Nervous System Agents
Central Nervous System Agents
Aprepitant

ClinicalTrials.gov processed this record on September 11, 2009