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A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)


OBJECTIVES:

Primary

- Compare the efficacy of standard antiemetic therapy comprising ondansetron and
dexamethasone combined with either aprepitant or placebo in controlling nausea and
vomiting, as determined by the number of retch/emesis-free days, in patients undergoing
hematopoietic stem cell transplantation.

Secondary

- Determine the safety of aprepitant in these patients.

- Compare nausea, appetite, taste changes, nutritional intake, and mucositis in patients
treated with these regimens.

- Determine the pharmacokinetics of cyclophosphamide, carboxyethylphosphoramide mustard,
hydroxycyclophylamide, and aprepitant in these patients.

OUTLINE: This is a randomized, placebo-controlled, single-blind, pilot study. Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Beginning on the first day of conditioning chemotherapy, patients receive oral
aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron
and oral dexamethasone.

- Arm II: Patients receive oral placebo once daily and standard antiemetic therapy as in
arm I.

In both arms, treatment continues until day 4 after stem cell transplant in the absence of
unacceptable toxicity.

After completion of study therapy, patients are followed until day 18.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study.

Inclusion Criteria


Inclusion:

- 18 years of age or greater

- must be scheduled for an autologous or allogeneic bone marrow or peripheral stem cell
transplant

- Eastern Cooperative Oncology Group(ECOG) performance status < or = 2

- patients must have signed informed consent

- must be able to swallow tablets and capsules

- must be receiving a cyclophosphamide containing regimen.

Exclusion:

- patient has known sensitivity to aprepitant, ondansetron, or dexamethasone

- patient has received another investigational drug in the past 30 days

- patient has had emesis or requires antiemetic agents in the 48 hours prior to
beginning conditioning therapy

- patient has taken neurokinin-1 antagonists for 14 days prior to enrollment

- patient is pregnant, has a positive serum human chorionic gonadotropin(hCg) or is
lactating

- patient has serum creatinine level > or = 2*ULN

- patient has severe hepatic insufficiency (Child-Pugh score >9)

- patient drinks > 5 drinks/day for the last year

- patient with concurrent illness requiring systemic corticosteroid use other than
planned dexamethasone during conditioning therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Number of Emesis Free Participants During the Study Period.

Outcome Description:

To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period

Outcome Time Frame:

Up to three weeks

Safety Issue:

No

Principal Investigator

Joseph Bubalo, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445452

NCT ID:

NCT00248547

Start Date:

May 2004

Completion Date:

January 2009

Related Keywords:

  • Cancer
  • 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
  • blastic phase chronic myelogenous leukemia
  • chronic eosinophilic leukemia
  • chronic idiopathic 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 disease, 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
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • poor prognosis metastatic gestational trophoblastic tumor
  • previously treated myelodysplastic syndromes
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent neuroblastoma
  • recurrent ovarian epithelial cancer
  • recurrent ovarian germ cell tumor
  • recurrent small lymphocytic lymphoma
  • recurrent malignant testicular germ cell tumor
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage II ovarian epithelial cancer
  • stage III adult Burkitt lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III multiple myeloma
  • stage III ovarian epithelial cancer
  • stage III small lymphocytic lymphoma
  • stage III malignant testicular germ cell tumor
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV adult Burkitt lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV breast cancer
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV ovarian epithelial cancer
  • stage IV small lymphocytic lymphoma
  • unspecified adult solid tumor, protocol specific
  • Lymphoma, Non-Hodgkin
  • Nausea
  • Vomiting
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239