Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

NCT00781768 | Completed Phase 4 Results

• 1 other identifier: 106578
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare two different treatment protocols for treating nausea and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned to one of two treatment groups. The first group will recieve ondansetron (Zofran) tablets combined with a medicine called dexamethasone given IV. Both of these drugs are commercially available. Patients in the second treatment consists of the first two drugs, plus a newly approved drug known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea and vomiting. It significantly decreases the delayed (more than 24 hours after therapy) nausea and vomiting seen with these regimens.

Conditions

Nausea; Vomiting

Keywords

Bone Marrow Transplant; Nausea; Vomiting; NK-1 antagonist

Outcome Measures

Primary Outcomes (1)

• Complete Response Rates Among Standard of Care and Combination Therapy Groups.

  Comparison of complete response (CR) rates between patients receiving ondansetron and dexamethasone and those receiving ondansetron and dexamethasone plus NK-1 antagonist, aprepitant. CR is defined as no emesis and with normal oral intake. Disease response not applicable.

  14 days

Study Arms (2)

Standard PO (Zofran + Dexamethasone)

PLACEBO COMPARATOR

Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron (Zofran) 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion.

Drug: Standard PO (Zofran + Dexamethason)

Aprepitant (MK-869) + Standard PO

ACTIVE COMPARATOR

Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.

Drug: Aprepitant (MK-869) + Standard PO

Interventions

Standard PO (Zofran + Dexamethason) DRUG

Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.

Also known as: Ondansetron (Zofran)

Standard PO (Zofran + Dexamethasone)

Aprepitant (MK-869) + Standard PO DRUG

Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.

Also known as: Ondansetron + Dexamethason (Standard PO)

Aprepitant (MK-869) + Standard PO

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO \& IV), and BCV
• Age 18 or older
• Alcohol intake \<100 gm/d for the last year (\< approximately 5 drinks per day)
• Renal function: estimated or measured CrCl 50 ml/min
• Liver function: T.Bili \<1.5, AST \< 2x ULN, unless due to disease
• Able to swallow tablets and capsules

You may not qualify if:

• Age \< 18
• High alcohol intake \[\> 100 gm/d in the last year\]
• Allergy or intolerance to: ondansetron or dexamethasone
• Renal dysfunction \[measured or estimated CrCl \< 50 ml/min\]
• Liver dysfunction \[T.Bili \> 1.5, AST \> 2x ULN, unless due to disease\]
• Inability to swallow tablets or capsules
• Concurrent condition requiring systemic steroid use
• History of anticipatory nausea and vomiting

Sponsors & Collaborators

• Loyola University: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Ondansetron; Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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; Morpholines; Oxazines

Limitations and Caveats

There are no limitations or caveats to disclose.

Results Point of Contact

• Title: Patrick Stiff, M.D.
• Organization: Loyola University Medical Center

pstiff@lumc.edu

708-327-3148

Study Officials

• Patrick Stiff, MD

  Loyola University Cardinal Bernadin Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of the Cardinal Bernardin Cancer Center

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 29, 2008
• Study Start: August 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: July 1, 2010
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-06