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Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide

Information source: Duke University
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea; Vomiting; Glioma

Intervention: Aprepitant (Drug); Ondansetron (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Katy Peters

Official(s) and/or principal investigator(s):
Mary Lou Affronti, DNP, RN, MSN, ANP, MHSc, Principal Investigator, Affiliation: Duke University
Katherine B Peters, MD, PhD, Principal Investigator, Affiliation: Duke University

Overall contact:
Mary Lou Affronti, DNP, RN, MSN, ANP, MHSc, Phone: 919-684-6239, Email: mary.affronti@duke.edu

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients achieving an acute and delayed complete response (CR)

Secondary outcome:

Proportion of patients achieving complete control (CC)

Patient's global satisfaction with the antiemetic regimen

Time to treatment failure

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must have histologically confirmed diagnosis of glioma (either low or high

grade) and be either chemotherapy naïve or non-naïve and scheduled to receive temozolomide-based +/- Bevacizumab- based chemotherapy. Patients with recurrent disease whose diagnostic pathology confirmed glioma (either low or high grade) will not need re-biopsy.

- Age ≥ 18 years

- ≤ 2 prior chemotherapeutic regimens

- Patient is scheduled to receive temozolomide at either 150 mg/m2 or 200mg/m2 by mouth

for 5 days out of a 28 day cycle +/- Bevacizumab.

- Study participation will occur during the first cycle of the 5 day temozolomide

course.

- An interval of at least 6 weeks between prior surgical resection and study enrollment

- The lab values following the prior chemotherapy must return within normal limits

prior to study enrollment.

- Karnofsky ≥ 60%.

- Hematocrit > 29%, ANC > 1,000 cells/µl, platelets > 100,000 cells/µl

- Serum creatinine < 1. 5 mg/dl, serum SGOT and bilirubin < 1. 5 times upper limit of

normal

- For patients on corticosteroids, they must have been on a stable dose for 1 week

prior to entry. The dexamethasone dose should not exceed > 4 mg every day and the dose should not be escalated over entry dose level, if clinically possible. All doses of 4 mg and less dexamethasone will be reduced by 50% to avoid drug to drug interactions with Aprepitant. It is recommended that dexamethasone doses be escalated back to full dose on Day 7 (2 days after Aprepitant is discontinued) based on Aprepitant half-life pharmacokinetic data, and expert clinical opinion.

- Signed informed consent approved by the Institutional Review Board prior to patient

entry

- If sexually active, patients will take contraceptive measures for the duration of

protocol treatment and continue until one month after treatment. The efficacy of hormonal contraceptives during and for 28 days following the last dose of Aprepitant may be reduced. Alternative or back-up methods of contraception must be used.

- Approved rescue medication for the treatment of nausea and vomiting is permitted at

the discretion of the investigator. The rescue antiemetics allowed will include: ondansetron, granisetron and lorazepam. Exclusion Criteria:

- Pregnant or breast-feeding (While both aprepitant and ondansetron are classified as

Category B drugs, an eligibility criteria for this study is that the patient be scheduled to receive a temozolomide-based chemotherapy regimen +/- bevacizumab, which are Category D and C drugs respectively. Therefore, while not considered necessary for the administration of the current study drugs, a pregnancy test should be a part of normal clinical care for the patients in this study, if the patient is determined to be of child-bearing potential.)

- No prior nitrosourea (e. g. lomustine, carmustine)

- Inability or unwillingness to understand or cooperate with study procedures

- Concurrent administration of CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs)

including phenytoin, phenobarbitol, carbamazepine, oxcarbazepine or primidone

- Prohibited medications: Patients taking CYP3A4 enzyme inducers and moderate or strong

inhibitors will be excluded from this trial. Also, patients receiving a maintenance decadron dose > 4mg every day will be excluded from this trial.

- Received any drug with potential anti-emetic effect within 24 hours prior to the

start of study-designated chemotherapeutic agent: HT3 receptor or substance P/neurokinin 1(NK1) receptor antagonists; Dopamine receptor antagonists (metoclopramide); Phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide; Haloperidol, droperidol, tetrahydrocannabinol, or nabilone

- Any vomiting, retching or NCI Common Toxicity Criteria v. 4.0 grade 2-4 nausea 24

hours preceding chemotherapy

- Ongoing vomiting from any organic etiology

- Will receive radiotherapy of cranium within one week prior to or during the study

Locations and Contacts

Mary Lou Affronti, DNP, RN, MSN, ANP, MHSc, Phone: 919-684-6239, Email: mary.affronti@duke.edu

The Preston Robert Tisch Brain Tumor Center at Duke, Durham, North Carolina 27710, United States; Recruiting
Mary Lou Affronti, RN, MSN, ANP, MHSc, Phone: 919-684-6239, Email: mary.affronti@duke.edu
Sarah Woodring, Phone: 919-684-2527, Email: sarah.woodring@duke.edu
Mary Lou Affronti, DNP, RN, MSN, ANP, MHSc, Principal Investigator
Katherine B Peter, MD, PhD, Principal Investigator
Additional Information

The Preston Robert Tisch Brain Tumor Center

Starting date: December 2012
Last updated: September 2, 2014

Page last updated: November 27, 2014

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