Aprepitant, Granisetron, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Cyclophosphamide Before a Stem Cell Transplant - Full Text View

Purpose

RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.

Condition	Intervention
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nausea and Vomiting Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor	Drug: Aprepitant Drug: Cyclophosphamide Drug: Dexamethasone Drug: Granisetron hydrochloride

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer familial acute myeloid leukemia with mutated CEBPA mycosis fungoides neuroblastoma primary myelofibrosis Sézary syndrome

MedlinePlus related topics: Acute Myeloid Leukemia Breast Cancer Cancer Cancer and Pregnancy Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Hodgkin Disease Leukemia Lymphoma Multiple Myeloma Myelodysplastic Syndromes Nausea and Vomiting Neuroblastoma Ovarian Cancer

Drug Information available for: Dexamethasone Cyclophosphamide Dexamethasone acetate Dexamethasone sodium phosphate Sodium phosphate Sodium phosphate, dibasic Granisetron hydrochloride Granisetron Aprepitant Fosaprepitant Fosaprepitant dimeglumine

U.S. FDA Resources

Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:

Acute vomiting controlled [ Time Frame: at 0-24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Delayed vomiting controlled [ Time Frame: at 25-120 hours ] [ Designated as safety issue: Yes ]
Overall nausea controlled [ Time Frame: at 0-120 hours ] [ Designated as safety issue: Yes ]
Toxicity grade 3, 4, or 5 [ Time Frame: at 0-120 hours ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	October 2004
Study Completion Date:	February 2012
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Aprepitant, Dexamethasone, Cytoxan & Kytril Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration. Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes. Days 2 & 3: Aprepitant 80 mg once daily in the morning.	Drug: Aprepitant Aprepitant 80mg once daily in the morning on days 2 and 3 Other Name: Emend Drug: Cyclophosphamide Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes Other Names: Cytoxan® Neosar® Drug: Dexamethasone Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration. Other Names: Decadron Diodex Hexadrol Maxidex Dexamethasone Sodium Phosphate Dexamethasone Acetate Drug: Granisetron hydrochloride Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration. Other Name: KYTRIL®

Arms

Assigned Interventions

Experimental: Aprepitant, Dexamethasone, Cytoxan & Kytril

Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.

Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.

Days 2 & 3: Aprepitant 80 mg once daily in the morning.

Drug: Aprepitant

Aprepitant 80mg once daily in the morning on days 2 and 3

Other Name: Emend

Drug: Cyclophosphamide

Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes

Other Names:

Cytoxan®
Neosar®

Drug: Dexamethasone

Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.

Other Names:

Decadron
Diodex
Hexadrol
Maxidex
Dexamethasone Sodium Phosphate
Dexamethasone Acetate

Drug: Granisetron hydrochloride

Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.

Other Name: KYTRIL®

Detailed Description:

OBJECTIVES:

Primary

Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.

Secondary

Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.
Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.
Identify side effects of the addition of aprepitant to this regimen in these patients.

OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone, followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable toxicity.

After completion of study treatment, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Undergoing autologous peripheral blood stem cell transplantation and stem cell mobilization using cyclophosphamide
Candidate (per institutional requirements) for autologous peripheral blood stem cell transplantation
- No psychiatric illness or multi-system organ failure
No nausea at baseline

PATIENT CHARACTERISTICS:

SWOG performance status 0-2
Fewer than 5 alcoholic drinks per day within the past year
No current illness requiring chronic systemic steroids or requirement for chronic use of anti-emetics
No gastrointestinal obstruction or active peptic ulcer disease
AST and ALT ≤ 3 times upper limit of normal (ULN)
Bilirubin ≤ 3 times ULN
Alkaline phosphatase ≤ 3 times ULN
Creatinine ≤ 2 mg/dL
No known hypersensitivity to any component of the study regimen
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No unrelenting hiccups

PRIOR CONCURRENT THERAPY:

No chronic therapeutic warfarin > 1 mg dose per day
No other concurrent investigational agents
No concurrent oral contraceptives (except for stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride
No concurrent illegal drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293384

Locations

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Muneer H. Abidi, MD

Barbara Ann Karmanos Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00293384 History of Changes
Other Study ID Numbers:	CDR0000456201, P30CA022453, WSU-D-2797, WSU-0504001728
Study First Received:	February 16, 2006
Last Updated:	August 6, 2012
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:

nausea and vomiting
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia

chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
myelodysplastic/myeloproliferative neoplasm, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Nausea
Vomiting
Neuroblastoma
Ovarian Neoplasms

Trophoblastic Neoplasms
Lymphoma, Large-Cell, Immunoblastic
Neoplasms, Germ Cell and Embryonal
Gestational Trophoblastic Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013