Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

Chemotherapy Induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02205164
• Other study ID #: AS/PALO/002
• Secondary ID: 2011-003823-36
• Status: Recruiting
• Phase: Phase 2
• First received: July 17, 2014
• Last updated: July 30, 2014
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: July 2014
• Source: Associazione Salentina Angela Serra
• Contact: Nicola Di Renzo, MD
• Email: direnzo.ematolecce[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapy Induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Palonosetron + Aprepitant
Aloxi 0.25mg Emend 125/80/80 mg
• Palonosetron
Aloxi 0.25mg

Locations

Country	Name	City	State
Italy	Università-Azienda Policlinico di Bari	Bari	BA
Italy	Ospedale Perrino	Brindisi	BR
Italy	Ospedale Pugliese-Ciacco	Catanzaro	CZ
Italy	Ospedale Vito Fazzi	Lecce	LE
Italy	A.O. Riuniti Papardo - Piemonte	Messina	ME
Italy	ARON " Cardarelli"	Napoli
Italy	Casa di Cura "La Maddalena"	Palermo	PA
Italy	Ospedale Ascoli Civico Palermo	Palermo	PA
Italy	IRCCS Casa Sollievo della Sofferenza	San Giovanni Rotondo	FG
Italy	Ospedale Moscati	Taranto	TA
Italy	Ospedale "Cardinale Panico"	Tricase	LE

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Salentina Angela Serra

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response	The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase.	5 days after chemotherapy	No
Secondary	Complete Control	No emetic episode, no need for rescue medication, with a maximum grade of mild nausea	5 days after chemotherapy	No
Secondary	Emesis-free	Percentage of patients without emetic episodes	5 days after chemotherapy	No
Secondary	Presence of nausea	Presence of nausea graded according to Likert scale (none, mild, moderate and severe)	5 days after chemotherapy	No
Secondary	Treatment failure	Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)	5 days after chemotherapy	No
Secondary	Patient global satisfaction	Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS)	5 days after chemotherapy	No
Secondary	Safety and tolerability	Number of patients experienced at least one adverse events related to study drug administration.	5 days after chemotherapy	No