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

NCT00415103 | Completed Phase 4 DMC

• 1 other identifier: 2006-00055-18
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Leukemia; Lymphoma

Keywords

Emesis; Nausea; leukemia; lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

  15 days

Study Arms (2)

1

EXPERIMENTAL

Aprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days Palonosetrón: 0.25 mg iv every 48 horas starting day 1

Drug: Aprepitant; Drug: Palonosetron

2

ACTIVE COMPARATOR

Granisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment.

Drug: Granisetron

Interventions

Aprepitant DRUG

Aprepitant: 125 mg oral day 1, follows by 80 mg oral every 24 hours in next days

1

Palonosetron DRUG

Palonosetrón: 0.25 mg iv every 48 hours, starting day 1

1

Granisetron DRUG

Granisetrón : 3 mg iv day, all days the patient will be treated with chemotherapy, and Aprepitant placebo 125 mg oral, day 1, and 80 mg next days in chemotherapy treatment

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

Hospital Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario la Princesa

Madrid, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Related Publications (2)

• Bosi 1993; Agura 1995; Okamoto 1996

  BACKGROUND

• MASCC Consensus Conference on Antihemetic Therapy, 2004)

  BACKGROUND

Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Leukemia; Lymphoma; Vomiting; Nausea

Interventions

Aprepitant; Palonosetron; Granisetron

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Bridged Bicyclo Compounds, Heterocyclic

Study Officials

• López Javier, Dr

  Hospital Universitario Ramon y Cajal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 22, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

ES (5)