Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
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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. |
- 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 |
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 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 May 23, 2013