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

NCT ID: NCT00248547

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2009-01-31

Brief 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.

Detailed 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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Aprepitant

Group Type: ACTIVE_COMPARATOR

aprepitant

Intervention Type: DRUG

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

dexamethasone

Intervention Type: DRUG

For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.

ondansetron

Intervention Type: DRUG

For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy

sugar pill

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

Group Type: PLACEBO_COMPARATOR

dexamethasone

Intervention Type: DRUG

For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.

ondansetron

Intervention Type: DRUG

For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy

placebo

Intervention Type: DRUG

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

Interventions

aprepitant

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

Intervention Type: DRUG

dexamethasone

For Cyclophosphamide Total Body Irradiation(CyTBI) patients: Dexamethasone study drug 1 capsule PO daily, 1 hour prior to chemotherapy with aprepitant on total body irradiation(TBI) and cyclophosphamide chemotherapy days; For Busulfan Cyclophosphamide(BuCy) patients: Dexamethasone 1 capsule orally once daily, discontinue after last dose of chemotherapy.

Intervention Type: DRUG

ondansetron

For CyTBI patients: Ondansetron 8 mg orally evert 12 hours, begin 1 hour prior to first TBI dose and discontinue after last dose; then Ondansetron 8 mg IV every 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy; For BuCy patients: Ondansetron 8 mg orally every 6 hours, begin 1 hour prior to first busulfan dose and discontinue after last busulfan dose is given. then: Ondansetron 8 mg IV Q 12 hours X 4 doses, begin 30 minutes prior to first cyclophosphamide chemotherapy

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Other Intervention Names

Emend; Decadron; Zofran; placebo, sugar pill

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph Bubalo

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Bubalo, PharmD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-HEM-03074-L

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-1057

Identifier Type: OTHER

Identifier Source: secondary_id

MERCK-OHSU-HEM-03074-L

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000445452

Identifier Type: -

Identifier Source: org_study_id