Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide
The objectives of the study are: 1) to assess the Chemotherapy Induced Nausea and Vomiting (CINV) efficacy and toxicity of Aprepitant in combination with Ondansetron vs Ondansetron alone in preventing acute CINV in brain tumor patients during the acute period (first 24 hours) of receiving 5 day temozolomide therapy; and 2) to assess the efficacy of Aprepitant in combination with Ondansetron vs Ondansetron alone in preventing delayed CINV (day 2-5).
Drug: Aprepitant and Ondansetron
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Open Label Phase II Trial of Aprepitant (Emend) in Combination With Ondansetron Compared to Standard 5HT3 Serotonin Antagonist (Ondansetron) in the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Glioma Patients Receiving a Temozolomide Based Regimen|
- Proportion of patients achieving an acute and delayed complete response (CR) [ Time Frame: 5 days ] [ Designated as safety issue: No ]Assessed from the beginning of study day 1, CR is defined for acute CINV as no emetic episode and no use of rescue anti-nausea medication during the first 24 hours following chemotherapy administration. CR is defined for delayed CINV as no emetic episode and no use of rescue anti-nausea medication on study days 2-5.
- Proportion of patients achieving complete control (CC) [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]Complete control (CC): study days 1-5 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication for the 0-24, 24-120 and 0-120 hour intervals; number of emetic episodes daily and cumulatively for the 24-120 and 0-120 hour intervals; time to first emetic episode; as captured by the Osoba survey. Severity of nausea and other toxicities measured daily for the 0-120 hour interval by the NCI Common Toxicity Criteria (version 4.0).
- Patient's global satisfaction with the antiemetic regimen [ Time Frame: 5 days ] [ Designated as safety issue: No ]Patient's global satisfaction with the antiemetic regimen as measured by the Osoba survey and validated modified functional living index—emesis (FLIE) questionnaire which specifically addresses the impact of nausea and emesis on daily functioning.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Emend (Aprepitant) and Ondansetron Regimen
Aprepitant in combination with Ondansetron on Days 1-5 of a 5-day oral temozolomide regimen
Drug: Aprepitant and Ondansetron
On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide). In addition, on day 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before the first dose of the 5-day oral temozolomide regimen (as well as on on days 2-5).
Active Comparator: Ondansetron Alone Regimen
Ondansetron alone on Days 1-5 of a 5-day oral temozolomide regimen
On day 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen (as well as on days 2-5).
Other Name: Zofran
One hundred and thirty-six (136) malignant glioma patients receiving temozolomide will be accrued in this open labeled phase II randomized single institution trial of Aprepitant in combination with Ondansetron vs. Ondansetron alone for the prevention of acute and delayed CINV. Sixty-eight (68) patients will be randomized to each arm of the study. Patient randomization will be stratified by grade (I/II vs. III/IV) and the number of prior progressions (0/1 versus 2). Within each of the 4 strata defined by these factors, a permuted block randomization scheme will be used to assign patients to receive either Ondansetron with or without Aprepitant.
Though the study is comparative, the goal of the study is to determine whether Aprepitant is worthy of further investigation in this setting, and not to make definitive statements about the comparative effectiveness Ondansetron treatment with or without Aprepitant.
|Contact: Mary Lou Affronti, RN, MSN, ANP, MHScfirstname.lastname@example.org|
|Contact: Sarah Woodringemail@example.com|
|United States, North Carolina|
|The Preston Robert Tisch Brain Tumor Center at Duke||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Mary Lou Affronti, RN, MSN, ANP, MHSc 919-684-6239 firstname.lastname@example.org|
|Contact: Sarah Woodring 919-684-2527 email@example.com|
|Principal Investigator: Mary Lou Affronti, RN, MSN, ANP, MHSc|
|Principal Investigator: Katherine B Peter, MD, PhD|
|Principal Investigator:||Mary Lou Affronti, RN, MSN, ANP, MHSc||Duke University|
|Principal Investigator:||Katherine B Peters, MD, PhD||Duke University|