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Low Dose Aprepitant for Patients Receiving Carboplatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237611
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Jacobi Medical Center
Information provided by (Responsible Party):
Albert Einstein College of Medicine

Brief Summary:
This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are getting carboplatin based chemotherapy. In addition to standard oral dexmethasone and oral ondansetrone, participants will be given a third neurokinin 1 (NK1) antagonist agent, either Aprepitant or Fosaprepitant (they have been shown to be equally effective) to improve prevention of nausea and vomiting. No medications need to be taken beyond day 1.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Drug: Aprepitant 125 mg Drug: Fosaprepitant 115 MG Drug: Dexamethasone Drug: Ondansetron 16 MG Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive 125mg of oral aprepitant or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Testing the Antiemetic Efficacy of a Single-day Low Dose Aprepitant (or Fosaprepitant) Added to a 5-HT3 Receptor Antagonist Plus Dexamethasone in Patients Receiving Carboplatin
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low dose aprepitant or fosaprepitant
In addition to standard prophylactic antiemetics (Ondansetron 16mg and Dexamethasone 20mg) patients will be given aprepitant 125mg orally or 115mg fosaprepitant intravenously prior to the first cycle of carboplatin-based chemotherapy. No medications will be given afterwards
Drug: Aprepitant 125 mg
Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting

Drug: Fosaprepitant 115 MG
Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting

Drug: Dexamethasone
Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy

Drug: Ondansetron 16 MG
Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy




Primary Outcome Measures :
  1. Complete control rate of emesis (this is a composite single endpoint which is commonly used in emesis trials. It encompasses no vomiting and no use of rescue medicines over a total 5-day period) [ Time Frame: Complete control rate over the 5 day period after chemotherapy ]
    Treatment efficacy will be determined by measuring complete control rate of emesis based on the visual scale analogue for emesis control, scored by patient from 0 to 10 (MAT form - MASCC Antiemesis Tool)


Secondary Outcome Measures :
  1. Complete control of emesis [ Time Frame: Complete control rate of emesis will be assessed on day 1 and 5 (both acute and delayed) ]
    To estimate the control rate on the second cycle of this chemotherapy in those patients agreeing to be assessed in the subsequent chemotherapy cycle.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No prior chemotherapy
  • Confirmed malignancy, scheduled to receive carboplatin monotherapy, or carboplatin in combination with agents of minimal, low, or moderate emetic potential
  • Laboratory parameters adequate for chemotherapy

Exclusion Criteria:

  • Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 or 4
  • Presence of nausea and vomiting or use of major antiemetic agents during the 24 hours before chemotherapy administration
  • Patients receiving radiotherapy within 5 days prior to the carboplatin
  • Pregnancy or lactation
  • Known allergy to any of the 3 antiemetics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237611


Contacts
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Contact: Karine Darbinyan, MD 917-736-3259 kdarbinyan1987@gmail.com
Contact: Richard Gralla, MD 718-918-6235 rgalla@gmail.com

Locations
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United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Rose Snyder, MD       rsnyder@montefiore.org   
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Karine Darbinyan, MD       kadarbin@montefiore.org   
Sponsors and Collaborators
Albert Einstein College of Medicine
Jacobi Medical Center
Investigators
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Principal Investigator: Richard Gralla, MD Albert Einstein College of Medicine
Additional Information:
Publications:
NCCN Guidelines, Antiemesis, Version I.2015
Yahata H, et al. Ann Oncol. 25 (Suppl 4): abstract 1481PD, 2014
Gralla R, Jordan K, Rapoport B et al. Assessing the magnitude of antiemetic benefit with the addition of the NK1 receptor antagonist (NK1) aprepitant for all platinum agents: analysis of 1,872 patients (pts) in prospective randomized clinical phase III trials (RCTs) [abstract9057]. J Clin Oncol 2010; 28: 9057.
Hesketh PJ, et al. Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in moderately emetogenic therapy (MEC). J Clin Oncol 33 (Suppl): abstract 9622, 2015
Matsuzaki K, ItoY, Fukuda M et al. Placebo-controlled phase III study comparing dexamethasone on day 1 to on day 1-3 with NK 1 receptor antagonist and palonosetoron in high emetogenic chemotherapy. J Clin Oncol 34, 2016 (suppl, abstract 10019)

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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03237611    
Other Study ID Numbers: 2015-5109
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Albert Einstein College of Medicine:
emesis
aprepitant
carboplatin
chemotherapy-induced nausea and vomiting
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Ondansetron
Aprepitant
Fosaprepitant
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Neurokinin-1 Receptor Antagonists