Breast Cancer Clinical Trial
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
Summary
RATIONALE: Antiemetic drugs, such as aprepitant, ondansetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant.
PURPOSE: This randomized clinical trial is studying aprepitant, ondansetron, and dexamethasone to see how well they work compared to placebo, ondansetron, and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant.
Full Description
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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Portland Oregon, 97239, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.