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

OHSU Knight Cancer Institute

Status: Completed

Conditions: Cancer

Treatments: Drug: placebo; Drug: aprepitant; Drug: dexamethasone; Drug: ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT00248547

MERCK-OHSU-HEM-03074-L (Other Identifier)

CDR0000445452

OHSU-HEM-03074-L (Other Identifier)

OHSU-1057 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Aprepitant

Active Comparator group

Treatment:

Drug: ondansetron

Drug: dexamethasone

Drug: aprepitant

sugar pill

Placebo Comparator group

Description:

Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant

Treatment:

Drug: ondansetron

Drug: dexamethasone

Drug: placebo