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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Palonosetron

ondansetron

Dexamethasone

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring Autologous stem cell transplant, BEAM, Oral busulfan, Cyclophosphamide, Etoposide, Carboplatin, melphalan

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northside Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Palonosetron

Arm Description

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

Outcomes

Primary Outcome Measures

Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting

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

Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)

Complete Remission During Overall Chemotherapy Time Period

Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period

Complete Control Rate for Nausea & Vomiting

Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)

Emetic Episodes

Number of emetic episodes

Patients Who Experience First Emetic Episode Within 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

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

Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours

Full Information

NCT ID

NCT01370408

First Posted

June 8, 2011

Last Updated

March 16, 2017

Sponsor

Northside Hospital, Inc.

Collaborators

Blood and Marrow Transplant Group of Georgia

1. Study Identification

Unique Protocol Identification Number

NCT01370408

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northside Hospital, Inc.

Collaborators

Blood and Marrow Transplant Group of Georgia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Nausea and Vomiting

Keywords

Autologous stem cell transplant, BEAM, Oral busulfan, Cyclophosphamide, Etoposide, Carboplatin, melphalan

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Palonosetron

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Palonosetron

Other Intervention Name(s)

Aloxi

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ondansetron

Other Intervention Name(s)

zofran

Intervention Description

Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Dex

Intervention Description

Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV

Primary Outcome Measure Information:

Title

Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting

Description

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.

Time Frame

120 hours

Secondary Outcome Measure Information:

Title

Complete Remission During Acute Phase Post-chemotherapy

Description

Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)

Time Frame

24 hours

Title

Complete Remission During Overall Chemotherapy Time Period

Description

Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period

Time Frame

120 hours

Title

Complete Control Rate for Nausea & Vomiting

Description

Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)

Time Frame

120 hours

Title

Emetic Episodes

Description

Number of emetic episodes

Time Frame

120 Hours

Title

Patients Who Experience First Emetic Episode Within 24 Hours

Description

Number of patients with first emetic episode experienced within 24 hours

Time Frame

24 hours

Title

Number of Patients That Required First Administration of Rescue Medication Within 24 Hours

Description

Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours

Time Frame

24 hours

Title

Number of Patients That Experience Treatment Failure Within the First 24 Hours

Description

Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott R Solomon, MD

Organizational Affiliation

Blood and Marrow Transplant Group of Georgia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northside Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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