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Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Blood and Marrow Transplant Group of Georgia
Information provided by (Responsible Party):
Northside Hospital, Inc.
ClinicalTrials.gov Identifier:
NCT01370408
First received: June 8, 2011
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.

Condition Intervention Phase
Chemotherapy-induced Nausea and Vomiting
Drug: Palonosetron
Drug: ondansetron
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy

Resource links provided by NLM:


Further study details as provided by Northside Hospital, Inc.:

Primary Outcome Measures:
  • Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting [ Time Frame: 120 hours ]
    Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.


Secondary Outcome Measures:
  • Complete Remission During Acute Phase Post-chemotherapy [ Time Frame: 24 hours ]
    Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)

  • Complete Remission During Overall Chemotherapy Time Period [ Time Frame: 120 hours ]
    Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period

  • Complete Control Rate for Nausea & Vomiting [ Time Frame: 120 hours ]
    Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)

  • Emetic Episodes [ Time Frame: 120 Hours ]
    Number of emetic episodes

  • Patients Who Experience First Emetic Episode Within 24 Hours [ Time Frame: 24 hours ]
    Number of patients with first emetic episode experienced within 24 hours

  • Number of Patients That Required First Administration of Rescue Medication Within 24 Hours [ Time Frame: 24 hours ]
    Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours

  • Number of Patients That Experience Treatment Failure Within the First 24 Hours [ Time Frame: 24 hours ]
    Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours


Enrollment: 85
Study Start Date: February 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palonosetron

All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation

Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV on the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO

Drug: Palonosetron
Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Other Name: Aloxi
Drug: ondansetron
Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
Other Name: zofran
Drug: Dexamethasone
Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
Other Name: Dex

Detailed Description:
In order to decrease this delayed CINV, the investigators have developed a unique schedule of antiemetics that takes advantage of palonosetron's long elimination half-life (40 hours). In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy. The investigators hypothesize that this antiemetic schedule will significantly reduce the delayed CINV compared to historical controls
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • candidate for high-dose chemotherapy and autologous hematopoietic stem cell transplantation
  • Karnofsky performance status >/= 60%
  • scheduled to receive one of the following conditioning regimens
  • BEAM
  • Oral Busulfan/cyclophosphamide with or without etoposide
  • Carboplatin/Etoposide
  • Melphalan
  • Negative pregnancy test
  • Must be able to complete a daily nausea/vomiting questionnaire and Quality of Life

Exclusion Criteria:

  • Active infection requiring IV antibiotics
  • Known active hepatitis B and/or hepatitis C or HIV infection
  • prior non-hematological malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer or other cancer from which the patient had been disease free for >/= 5 years
  • Uncontrolled medical problems including any of the following
  • Diabetes mellitus
  • Cardiac, pulmonary, hepatic or renal disease
  • myocardial infarction within the past 6 months
  • Morbid obesity (BMT >40)
  • History of CNS metastases, psychiatric or CNS disorders interfering with the ability to comply with the study
  • Known hypersensitivity to 5-HT3 antagonists, dexamethasone and/or their components
  • Intrathecal therapy within 24 hours before starting preparative regimen
  • Receiving any antiemetic therapy 24 hours before starting preparative regimen
  • Any 5-HT3 antagonist used as a rescue medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370408

Locations
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Northside Hospital, Inc.
Blood and Marrow Transplant Group of Georgia
Investigators
Principal Investigator: Scott R Solomon, MD Blood and Marrow Transplant Group of Georgia
  More Information

Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01370408     History of Changes
Other Study ID Numbers: NSH 940 
Study First Received: June 8, 2011
Results First Received: October 6, 2016
Last Updated: December 12, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Northside Hospital, Inc.:
Autologous stem cell transplant
BEAM
Oral busulfan
Cyclophosphamide
Etoposide
Carboplatin
melphalan

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Palonosetron
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents

ClinicalTrials.gov processed this record on February 23, 2017