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

Chemotherapy-induced Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01370408
• Other study ID #: NSH 940
• Status: Recruiting
• Phase: Phase 2
• First received: June 8, 2011
• Last updated: February 29, 2016
• Start date: February 2012
• Est. completion date: June 2016

Study information

• Verified date: February 2016
• Source: Northside Hospital, Inc.
• Contact: Stacey Brown, BA
• Phone: 404-851-8238
• Email: stacey.brown[@]Northside.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

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

Locations

Country	Name	City	State
United States	Northside Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Northside Hospital, Inc.	Blood and Marrow Transplant Group of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate for delayed chemotherapy induced nauseas & 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.	120 hours	No
Secondary	Complete remission during acute phase post-chemotherapy	Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)	24 hours	No
Secondary	Complete remission during overall chemotherapy time period	Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period	120 hours	No
Secondary	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)	120 hours	No
Secondary	Emetic episodes	Number of emetic episodes	120 Hours	No
Secondary	First emetic episode	Time to first emetic episode	120 hours	No
Secondary	First administration of rescue medication	Time to first administration of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol)	120 hours	No
Secondary	Treatment failure	Time to treatment failure (i.e. time to first emetic episode or time to administration of rescue therapy, whichever occurred first)	120 hours	No
Secondary	Severity of nausea	Severity of nausea, using a numerical scale of 1-10 categorized as none (1), mild (2-4), moderate (5-7), severe (8-10)	120 hours	No
Secondary	Quality of life (QOL)	Quality of life using the FLIE	120 hours	No