Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00248547
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2005-11-03
Brief Title:
Aprepitant in Preventing Nausea and Vomiting in Patients Who Are Undergoing a Stem Cell Transplant
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Pilot Study of Aprepitant vs Placebo Combined With Standard Antiemetics for the Control of Nausea and Vomiting During Hematopoietic Cell TransplatationHCT
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antiemetic drugs such as aprepitant ondansetron and dexamethasone may help lessen or prevent nausea and vomiting in patients undergoing a stem cell transplant
PURPOSE This randomized clinical trial is studying aprepitant ondansetron and dexamethasone to see how well they work compared to placebo ondansetron and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant
PURPOSE This randomized clinical trial is studying aprepitant ondansetron and dexamethasone to see how well they work compared to placebo ondansetron and dexamethasone in preventing nausea and vomiting in patients who are undergoing a stem cell transplant
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting as determined by the number of retchemesis-free days in patients undergoing hematopoietic stem cell transplantation
Secondary
Determine the safety of aprepitant in these patients
Compare nausea appetite taste changes nutritional intake and mucositis in patients treated with these regimens
Determine the pharmacokinetics of cyclophosphamide carboxyethylphosphoramide mustard hydroxycyclophylamide and aprepitant in these patients
OUTLINE This is a randomized placebo-controlled single-blind pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on the first day of conditioning chemotherapy patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone
Arm II Patients receive oral placebo once daily and standard antiemetic therapy as in arm I
In both arms treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity
After completion of study therapy patients are followed until day 18
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
Primary
Compare the efficacy of standard antiemetic therapy comprising ondansetron and dexamethasone combined with either aprepitant or placebo in controlling nausea and vomiting as determined by the number of retchemesis-free days in patients undergoing hematopoietic stem cell transplantation
Secondary
Determine the safety of aprepitant in these patients
Compare nausea appetite taste changes nutritional intake and mucositis in patients treated with these regimens
Determine the pharmacokinetics of cyclophosphamide carboxyethylphosphoramide mustard hydroxycyclophylamide and aprepitant in these patients
OUTLINE This is a randomized placebo-controlled single-blind pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Beginning on the first day of conditioning chemotherapy patients receive oral aprepitant once daily and standard antiemetic therapy comprising oral or IV ondansetron and oral dexamethasone
Arm II Patients receive oral placebo once daily and standard antiemetic therapy as in arm I
In both arms treatment continues until day 4 after stem cell transplant in the absence of unacceptable toxicity
After completion of study therapy patients are followed until day 18
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MERCK-OHSU-HEM-03074-L | OTHER | Merck | None |
| OHSU-HEM-03074-L | OTHER | None | None |
| OHSU-1057 | OTHER | None | None |