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NCT00293384 · REGISTRY CONDITION SEARCH

Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2016-03-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Proportion of Participants With Controlled Acute Vomiting

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outcome · POSTED

Delayed Vomiting Controlled

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outcome · POSTED

Overall Nausea Controlled

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outcome · POSTED

Toxicity Grade 3, 4, or 5

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Aprepitant
    2. Drug: Cyclophosphamide
    3. Drug: Dexamethasone
    4. Drug: Granisetron hydrochloride
    label
    Aprepitant, Dexamethasone, Cytoxan & Kytril
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Aprepitant, Dexamethasone, Cytoxan & Kytril
    description
    Aprepitant 80mg once daily in the morning on days 2 and 3
    name
    Aprepitant
    other Names
    1. Emend
    type
    DRUG
  2. arm Group Labels
    1. Aprepitant, Dexamethasone, Cytoxan & Kytril
    description
    Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes
    name
    Cyclophosphamide
    other Names
    1. Cytoxan®
    2. Neosar®
    type
    DRUG
  3. arm Group Labels
    1. Aprepitant, Dexamethasone, Cytoxan & Kytril
    description
    Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.
    name
    Dexamethasone
    other Names
    1. Decadron
    2. Diodex
    3. Hexadrol
    4. Maxidex
    5. Dexamethasone Sodium Phosphate
    6. Dexamethasone Acetate
    type
    DRUG
  4. arm Group Labels
    1. Aprepitant, Dexamethasone, Cytoxan & Kytril
    description
    Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.
    name
    Granisetron hydrochloride
    other Names
    1. KYTRIL®
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
40
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. measure
    Overall Nausea Controlled
    time Frame
    at 0-120 hours
primary Outcomes
  1. description
    No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.
    measure
    Proportion of Participants With Controlled Acute Vomiting
    time Frame
    at 0-24 hours
secondary Outcomes
  1. measure
    Delayed Vomiting Controlled
    time Frame
    at 25-120 hours
  2. measure
    Toxicity Grade 3, 4, or 5
    time Frame
    at 0-120 hours
Full study description
brief Summary
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.
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.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice