Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Ondansetron

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