Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation

NCT ID: NCT00314743

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-12-31

Brief Summary

The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control (No aprepitant)

Regimen #1 (BEAM; NHL and HL)

Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV)

Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 20 mg IV)

Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication)

Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV)

Regimen #2 (MM and Amyloidosis)

Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 20 mg IV)

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Experimental (with aprepitant)

Aprepitant 125 mg PO will be given 30 minutes prior to the first dose of chemotherapy followed by Aprepitant 80 mg PO QD for the remainder of chemotherapy and continuing for a total of 2 days after completing the regimen.

Regimen #1 (BEAM; NHL and HL)

Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV)

Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 10 mg IV)

Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication)

Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV)

Regimen #2 (MM and Amyloidosis)

Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 10 mg IV)

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Aprepitant

Intervention Type: DRUG

Interventions

Ondansetron

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Aprepitant

Intervention Type: DRUG

Other Intervention Names

Zofran; Emend

Eligibility Criteria

Inclusion Criteria

• Male or female patients 18 years of age or older

Exclusion Criteria

• Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
• Written informed consent

• Nausea at baseline
• Chronic use of other antiemetic agent(s)
• Gastrointestinal obstruction or active peptic ulcer
• Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
• Allogeneic stem cell transplant recipient
• Aspartate transaminase (AST) > 3x upper limit of normal (ULN)
• Alanine transaminase (ALT) > 3x ULN
• Bilirubin > 3x ULN
• Alkaline phosphatase > 3x ULN
• Creatinine > 2
• Documented hypersensitivity to any component of study regimen
• Pregnant or lactating women
• Participating in a clinical trial which involves other investigational agent(s)
• Patients taking any of the following medications at time of study day 1: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.

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

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John F DiPersio, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

03-1192

Identifier Type: -

Identifier Source: org_study_id

NCT00285272

Identifier Type: -

Identifier Source: nct_alias