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

Cancer Clinical Trial

Official title:

A Pilot Study of Aprepitant vs. Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell Transplatation(HCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248547
• Other study ID #: CDR0000445452
• Secondary ID: OHSU-HEM-03074-L
• Status: Completed
• Phase: N/A
• First received: November 3, 2005
• Last updated: May 7, 2017
• Start date: May 2004
• Est. completion date: January 2009

Study information

• Verified date: May 2017
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Nausea
• Vomiting

Intervention

Drug:
• 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
• 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.
• 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
• 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

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Emesis Free Participants During the Study Period.	To compare the efficacy of aprepitant plus standard therapy to placebo plus standard therapy in control of nausea and vomiting during conditioning therapy for autologous or allogeneic hematopoietic stem cell transplantation (HSCT) as defined by the number of retch/emesis free days during the study period	Up to three weeks
Secondary	Safety in Transplant Population	To assess the safety of aprepitant in the bone marrow transplant population	Up to three weeks
Secondary	Effects on Nausea, Appetite and Taste Changes	To assess the effects of aprepitant on nausea, appetite, and taste changes, (via visual analogue scale [VAS]), nutritional intake, and mucositis in the bone marrow transplant population.	Up to three weeks
Secondary	Pharmacokinetic Interaction	To assess the potential for aprepitant and cyclophosphamide to interact pharmacokinetically in a significant manner to change blood levels of aprepitant, cyclophosphamide, hydroxycyclophosphamide or CEPM.	Up to three weeks