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

Sponsor:	Washington University School of Medicine
Information provided by (Responsible Party):	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00314743

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
Nausea Vomiting	Drug: Carmustine, Etoposide, Cytarabine, Melphalan Drug: Aprepitant, Carmustine, Etoposide, Cytarabine, Melphalan

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Pilot 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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Cytarabine hydrochloride Etoposide Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron Etoposide phosphate Aprepitant Cytarabine Melphalan Carmustine Sarcolysin Dexamethasone Sodium Phosphate Melphalan hydrochloride

U.S. FDA Resources

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: Duration of Study ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	March 2006
Study Completion Date:	February 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Control	Drug: Carmustine, Etoposide, Cytarabine, Melphalan 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 hrs 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 hrs x 8 doses on days -6 to -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 of melphalan with ondansetron 32 mg IV and dexamethasone 20 mg IV
Experimental: 2	Drug: Aprepitant, Carmustine, Etoposide, Cytarabine, Melphalan 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 conditioning regimen. Aprepitant will not be repeated if emesis occurs shortly after PO drug injection. 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 hrs x 8 doses on days -6 to -3 Premedicate first daily dose with ondansetron 32 mg IV and dexamethasone 10 mg IV Cytarabine 100 mg/m2 IV Q 12 hrs x 8 doses on days -6 to -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 of melphalan with ondansetron 32 mg IV and dexamethasone 10 mg IV

Arms

Assigned Interventions

1

Control

Drug: Carmustine, Etoposide, Cytarabine, Melphalan

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 hrs 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 hrs x 8 doses on days -6 to -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 of melphalan with ondansetron 32 mg IV and dexamethasone 20 mg IV

Experimental: 2

Drug: Aprepitant, Carmustine, Etoposide, Cytarabine, Melphalan

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 conditioning regimen. Aprepitant will not be repeated if emesis occurs shortly after PO drug injection.

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 hrs x 8 doses on days -6 to -3 Premedicate first daily dose with ondansetron 32 mg IV and dexamethasone 10 mg IV
Cytarabine 100 mg/m2 IV Q 12 hrs x 8 doses on days -6 to -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 of melphalan with ondansetron 32 mg IV and dexamethasone 10 mg IV

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 or Multiple Myeloma
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
Known hypersensitivity to any component of study regimen
Pregnant or lactating women
Participating in a clinical trial which involves other investigational agent(s)

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:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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:	September 22, 2011
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
Carmustine
Melphalan
Etoposide phosphate
Cytarabine
Dexamethasone
Etoposide
Dexamethasone acetate
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101

Substance P
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 13, 2012