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

Northside Hospital, Inc.

Status and phase: Completed; Phase 2

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Drug: ondansetron; Drug: Palonosetron; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01370408

NSH 940

Details and patient eligibility

About

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.

Full 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

Enrollment: 85 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Palonosetron

Experimental group

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

Treatment:

Drug: Palonosetron

Drug: Dexamethasone

Drug: ondansetron