Trial | NCT02205164  Report issue

Title

Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients
Phase II Randomized Study of Multiple Doses of Palonosetron Plus Aprepitant Versus Multiple Doses of Palonosetron Alone in Preventing CINV in Patients With Newly Diagnosed AML or High-risk MDS Receiving Multiple Days Chemotherapy

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    134
The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.
This is an open-label, randomized, comparative, multicenter phase II study in patients with AML scheduled to receive multiple days chemotherapy.

Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a computer-generated, random allocation schedule. Below are described the details for both antiemetic regimens:

PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1 hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.
Study Started
Oct 31
2011
Primary Completion
Aug 31
2014
Anticipated
Study Completion
Oct 31
2014
Anticipated
Last Update
Jul 31
2014
Estimate

Drug Palonosetron

Aloxi 0.25mg

  • Other names: Aloxi

Drug Palonosetron + Aprepitant

Aloxi 0.25mg Emend 125/80/80 mg

  • Other names: Aloxi + Emend

Palonosetron + Aprepitant Experimental

Oral aprepitant will be given on days 1-3 (day 1, 125 mg 1 h before chemohterapy; days 2-3, 80 mg) multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.

Palonosetron Active Comparator

multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.

Criteria 

Inclusion Criteria:

Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS
Patient eligible for AML-like induction therapy
Candidate for multiple-days chemotherapy (minimum 3 days)
Age more, equal18 years
ECOG 0-2
Not pregnant or nursing
Must be able to complete the patient's diary
Provide written informed consent

Exclusion Criteria:

AML or HR-MDS therapy-related
Active infection requiring intravenous antibiotics
Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for more/equal 5 years
Unacceptable hepatic function (more of 2 times the upper limit of normal for liver transaminases) and renal function (creatinine more of 1.5 times the upper limit of normal) unless disease-related
Myocardial infarction within the past 6 months
Psychiatric or CNS disorders interfering with ability to comply with study protocol
Known hypersensitivity to 5-HT3 antagonists and their components CSF involvement
Pre-existing nausea or vomiting
No Results Posted