AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to determinate the security, tolerability and efficacy of aprepitant plus palonosetron versus granisetron in the prevention of nausea and emesis induced by chemotherapy in patients treated with haematopoietic progenitors transplant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PETHEMA Foundation
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; Fosaprepitant; Granisetron; Palonosetron

Criteria

Inclusion Criteria:

• Patients 18 years old or up

• Will go through a Haematopoietic progenitors transplant (of mother cells from periphery blood or bone marrow with at least a 5 days long previous regime (with or without radiotherapy)

• women in fertile age must give negative in the pregnancy test in serum or in urine, sensible to 25 UI of β-hCG, in the visit before the study and accept to use a contraceptive double barrier method at least from the 14 previous days to the administration of the first dose of the study drug to the 14 following days after the last dose.

• Patient has a Karnofsky punctuation ≥60

• Patient has an life expectancy ≥1 month

• Patient is capable to read, understand and to complete the study questionnaires including the questions which require a visual analogy scale answer

• Patient understands the study procedure and agrees to participate in it, giving his written consent.

• Patient is going through one of these previous regimens:

• CBV (ciclofosfamide, BCNU and VP-16)

• BEAM (BCNU, VP-16, araC, melphalan)

• Regimens with BUCY (Busulfan x 4 days and ciclofosfamide with or without other agents)

• CYTBI (ciclofosfamide plus total body irradiation with/without others agents)

Exclusion Criteria:

• Patients that are in one of these situations if, according to investigator's opinion, it prevents their participation in the study.

• Mental disability or emotional or psychiatric significant disorder

• Patient consumes any kind of drug, included marijuana, or the investigator determines that he has excessive alcohol consumption.

• Patient has any kind of infection (e.g. pneumonia) or any other uncontrolled disease (e.g. digestive obstruction) different to the process that, in the investigator's opinion, could mix the study's results or put the patient at risk if the drug is administrated.

• Patient has history of hypersensitivity to granisetron, palonosetron or aprepitant.

• Patient has received any non proven drug (investigation) in the last 4 weeks.

• Patient has history or present history of cardiac conduction disorders specially QTC interval. Anti-arrhythmic use or electrolytic disorders capable of giving cardiac conduction disorders.

• Abnormal lab values

• AST >2.5 X superior limit of normality

• ALT >2.5 x superior limit of normality

• Bilirubin >1.5 x superior limit of normality

• Creatinine >1.5 x superior limit of normality

• Patients that in the 48 hours before day 1 of the study they have been treated with the following antiemetics:

• 5HT-3 antagonist (ondansetron, granisetron, dolasetron, or tropisetron)

• Fenotiacines

• Butyrophenones: (haloperidol or droperidol)

• Benzamides: metoclopramide or alizapride

• Domperidone

• Cannabinoids

• Patient who has started to receive treatment with benzodiazepines or with opioids in the first 48 hours before the day 1 of the study, except unique daily doses of triazolam, temazepam, lorazepam and midazolam. The continuation of the chronic treatment with benzodiazepins or with opioids is authorized as long as this treatment has been initiated at least 48 hours before day 1 of the study (considering that they can increase their levels.)

• Patient is taking or has taken in the 7 days before day 1 of the study the following substrates of the CYP3A4:

• Terfenadine

• Cisapride

• Astemizol

• Pimozide Or the following CYTP3A4 inhibitors

• clarithromycin : azithromycin, erythromicin aroxithromycin nd are allowed

• Ketoconazole or itraconazole (fluconazol is allowed)

• Patient is taking or has taken in the 30 days before day 1 of the study the following substrates of the CYP3A4:

• Barbiturics

• Rifampicin or rifabutin

• Carbamazepin or fenitoin. The administration of fenitoin as prophylaxis in regimens with busulfan of short duration is allowed in the following cases:

• This is a common regimen of conditioning in the transplant:

• The short time of treatment together -5 days maximum- and

• With the recommendation to monitorize the levels of fenitoin (keeping in mind that the mutual interaction between aprepitant and fenitoin can decrease the level of both.)

• Patient is taking or has taken in the 7 days before day 1 of the study, steroids (They can be administrated as a rescue antiemetic if it is indicated)