Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide
The objectives of the study are: 1) Primary: Assess CINV efficacy of Aprepitant in combination with Ondansetron vs. Ondansetron alone in preventing acute and delayed CINV (Complete Control (CC): days 1-7) in brain tumor patients during adjuvant temozolomide therapy; and 2) Secondary: To assess the efficacy 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 adjuvant temozolomide therapy; 3)Secondary: To assess the efficacy of Aprepitant in combination with Ondansetron vs. Ondansetron alone in preventing delayed CINV (days 2-7); 4) Secondary: To assess the safety and tolerability of Aprepitant administered concomitantly with Ondansetron; 5) Exploratory: To assess the time to treatment failure of Ondansetron treatment with and without Aprepitant; 6) Exploratory: To explore the effects of age, gender, chemotherapy history, and concomitant glucocorticoid on the efficacy of Ondansetron treatment with and without Aprepitant; 7) Exploratory: To explore the impact of Aprepitant on quality of life and daily function.
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: 7 days ] [ Designated as safety issue: No ]CR is the proportion of patients with no emetic episode and no rescue medication. (1) 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. An emetic episode is defined as one episode of vomiting or a sequence of episodes in very close succession not relieved by a period of relaxation of at least 1 min, any number of unproductive emetic episodes (retches) in any given 5 minute period, or an episode of retching lasting <5 minutes combined with vomiting not relieved by a period of relaxation of at least 1 minute; (2) Complete response (CR) on study days 2-7 (delayed CINV) is defined as the proportion of patients achieving a CR during the delayed time period. The data will be captured by the validated MAT/Osoba survey.
- Proportion of patients achieving complete control (CC) [ Time Frame: 7 days ] [ Designated as safety issue: No ]Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4.0).
- Patient's global satisfaction with the antiemetic regimen [ Time Frame: 7 days ] [ Designated as safety issue: No ]Patient's global satisfaction with the antiemetic regimen as measured by the Osoba survey. This survey will be administered at baseline and for day 1 (acute period) and for days 2-7 (delayed period) to determine overall global satisfaction (Acute and delayed combined to determine overall CC, days 1-7).
- Time to treatment failure [ Time Frame: 7 days ] [ Designated as safety issue: No ]First emetic episode or first need of rescue medication, whichever occurred first as measured by the MAT/Osoba survey, which indicates time of first emetic episode or rescue medication.
|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 of Ondansetron treatment with or without Aprepitant.
|Contact: Mary Lou Affronti, DNP, 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, DNP, RN, MSN, ANP, MHSc|
|Principal Investigator: Katherine B Peter, MD, PhD|
|Principal Investigator:||Mary Lou Affronti, DNP, RN, MSN, ANP, MHSc||Duke University|
|Principal Investigator:||Katherine B Peters, MD, PhD||Duke University|