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

This study is currently recruiting participants.
Verified March 2013 by Northside Hospital, Inc.
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: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Complete Response Rate for delayed chemotherapy induced nauseas & vomiting [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of emetic episodes

  • First emetic episode [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
    Time to first emetic episode

  • First administration of rescue medication [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
    Time to first administration of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol)

  • Treatment failure [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
    Time to treatment failure (i.e. time to first emetic episode or time to administration of rescue therapy, whichever occurred first)

  • Severity of nausea [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
    Severity of nausea, using a numerical scale of 1-10 categorized as none (1), mild (2-4), moderate (5-7), severe (8-10)

  • Quality of life (QOL) [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
    Quality of life using the FLIE


Estimated Enrollment: 85
Study Start Date: February 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (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

Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO

 Drug: Palonosetron, ondansetron, dexamethasone
Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Other Names:
  • Aloxi
  • Zofran

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370408

Contacts
Contact: Stacey Brown, BA 404-851-8238 stacey.brown@Northside.com
Contact: Justin Laporte, PharmD 404-255-1930 justin.laporte@northside.com

Locations
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Stacey Brown, BA     404-851-8238     stacey.brown@northside.com    
Contact: Justin Laporte, PharmD     404-255-1930     justin.laporte@northside.com    
Sub-Investigator: H. Kent Holland, MD            
Sub-Investigator: Asad Bashey, MD            
Sub-Investigator: Lawrence E Morris, MD            
Sub-Investigator: Justin Laporte, PharmD            
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

No publications provided

Responsible Party: Northside Hospital, Inc.
ClinicalTrials.gov Identifier: NCT01370408     History of Changes
Other Study ID Numbers: NSH 940
Study First Received: June 8, 2011
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
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

ClinicalTrials.gov processed this record on May 16, 2013