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Completed

NCT Number: NCT01370408

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

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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northside Hospital

Atlanta, Georgia, 30342, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron

Drug

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 names: Aloxi

ondansetron

Drug

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 names: zofran

Dexamethasone

Drug

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 names: Dex

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. 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)

  4. Emetic Episodes

    Time frame: 120 Hours

    Number of emetic episodes

  5. Patients Who Experience First Emetic Episode Within 24 Hours

    Time frame: 24 hours

    Number of patients with first emetic episode experienced within 24 hours

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Collaborators

  • Blood and Marrow Transplant Group of Georgia

Registry information

Official study title

A Unique Schedule of Palonosetron, Ondansetron, and Dexamethasone for the Prevention of Delayed Nausea and Vomiting in Patients Receiving Moderately Emetogenic Myeloablative Chemotherapy

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2011
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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