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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00314743
First received: April 12, 2006
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Drug: Ondansetron
Drug: Dexamethasone
Drug: Aprepitant
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine the efficacy of aprepitant in preventing acute & delayed chemotherapy induced nausea & vomiting when administered in combination with intravenous or oral ondansetron & intravenous or oral dexamethasone in the autologous transplant setting. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the the severity, frequency, and duration of chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to a control group, not receiving aprepitant. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • To assess the incidence of complications associated with chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to the control group. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
  • To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting. [ Time Frame: Day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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)

Drug: Ondansetron
Other Name: Zofran
Drug: Dexamethasone
Experimental: 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)

Drug: Ondansetron
Other Name: Zofran
Drug: Dexamethasone Drug: Aprepitant
Other Name: Emend

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients 18 years of age or older
  • Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
  • Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
  • Written informed consent

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314743

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: John F DiPersio, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00314743     History of Changes
Obsolete Identifiers: NCT00285272
Other Study ID Numbers: 03-1192
Study First Received: April 12, 2006
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Patients with Non-Hodgkins Lymphoma or Multiple Myeloma

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Substance P
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antipruritics

ClinicalTrials.gov processed this record on April 22, 2014