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

NCT00314743 | Completed Early Phase 1

• 1 other identifier: 03-1192
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Patients with Non-Hodgkins Lymphoma or Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 30

Secondary Outcomes (4)

• 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.

  Day 30

• To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group

  Day 30

• 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.

  Day 30

• To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting.

  Day 30

Study Arms (2)

Control (No aprepitant)

ACTIVE COMPARATOR

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; Drug: Dexamethasone

Experimental (with aprepitant)

EXPERIMENTAL

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; Drug: Dexamethasone; Drug: Aprepitant

Interventions

Ondansetron DRUG

Also known as: Zofran

Control (No aprepitant); Experimental (with aprepitant)

Dexamethasone DRUG

Control (No aprepitant); Experimental (with aprepitant)

Aprepitant DRUG

Also known as: Emend

Experimental (with aprepitant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 years of age or older

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Nausea; Vomiting; Multiple Myeloma

Interventions

Ondansetron; Dexamethasone; Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Morpholines; Oxazines

Study Officials

• John F DiPersio, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2006
• First Posted: April 14, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (1)