N/A Completed N=40 Supportive Care

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

Breast Cancer · Chronic Myeloproliferative Disorders · Gestational Trophoblastic Tumor · leukemia

Source: ClinicalTrials.gov NCT00293384 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Oct 2014

Primary outcomePrimary: Proportion of Participants With Controlled Acute Vomiting — 20 participants — p=0.10

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With Controlled Acute Vomiting	20	0.10
SECONDARY Delayed Vomiting Controlled	22	—
SECONDARY Toxicity Grade 3, 4, or 5	2	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00293384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.