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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00781768
First received: October 27, 2008
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Drug: Standard PO ondansetron + dexamethasone
Drug: aprepitant (MK-869) + PO ondansetron + dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Phase III Trial of Oral Ondansetron and Dexamethasone Versus Oral Ondansetron, Dexamethasone and Apreptant (MK-869)for the Prevention of N/V Associated With Highly Emetogenic Preparative Regimens Prior to Stem Cell Transplantation.

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • To compare rate of complete response and toxicity during and 3 days after high dose therapy in pts treated with NK-1 antagonist, aprepitant, plus ondansetron and dexamethasone compared to ondansetron and dexam [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: August 2003
Study Completion Date: July 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Standard PO ondansetron + dexamethasone
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.
Active Comparator: 2 Drug: aprepitant (MK-869) + PO ondansetron + dexamethasone
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.

Detailed Description:

This will be a single center, comparative, randomized, double-blind, phase III trial designed to evaluate the efficacy of the NK-1 antagonist, aprepitant (MK-869), in combination with ondansetron and dexamethasone in the prevention of acute and delayed nausea and vomiting compared to ondansetron and dexamethasone in patients receiving highly emetogenic preparative regimens prior to autologous or allogeneic (related and unrelated) stem cell transplantation.

Patients will be randomized to one of two treatments: dexamethasone 10 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day vs. 7.5 mg IV once daily and ondansetron 8 mg orally every 8 hours on each day of the preparative regimen plus one additional day combined with aprepitant, 125 mg orally on the first day of their preparative regimen followed by 80 mg daily on each remaining day of the preparative regimen plus three additional days.

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Nonmyeloablative SCT, patients receiving the conditioning regimens not included [see inclusion criteria]
  • History of anticipatory nausea and vomiting
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781768

Sponsors and Collaborators
Loyola University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Patrick Stiff, MD Loyola University Cardinal Bernadin Cancer Center
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00781768     History of Changes
Other Study ID Numbers: 106578
Study First Received: October 27, 2008
Last Updated: September 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Loyola University:
Bone Marrow Transplant
Nausea
Vomiting
NK-1 antagonist
Nausea and vommitting in the stem cell/marrow transplant population.

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ondansetron
Aprepitant
Dexamethasone 21-phosphate
BB 1101
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
Antipruritics
Dermatologic Agents
Serotonin Antagonists

ClinicalTrials.gov processed this record on July 20, 2014