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Fosaprepitant for Breakthrough Chemotherapy Induced Nausea and Vomiting

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00939302
First received: July 13, 2009
Last updated: April 30, 2013
Last verified: April 2013
History of Changes
  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
Nausea
Vomiting
 Drug: fosaprepitant
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • The primary analysis will utilize a Wilcoxon signed rank test to compare the change from baseline to 2 hours post-treatment initiation. [ Time Frame: 2 hours post study drug administration ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: December 2009
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosaprepitant Drug: fosaprepitant
150 mg IV once at time of subject breakthrough CINV
Other Name: Emend

  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

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Joseph Bubalo, PharmD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00939302     History of Changes
Other Study ID Numbers: HEM-08053-L, IRB#4498
Study First Received: July 13, 2009
Last Updated: April 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
breakthrough CINV
fosaprepitant
breakthrough chemotherapy induced nausea and vomiting

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

ClinicalTrials.gov processed this record on May 22, 2013