Pro00031206 - Emend with Ondansetron

Clinical Trials for Adults | 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

Purpose:
To assess the 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 in delayed CINV (days 2-5)

Design and Procedures:  

  • Non-EIAED patients only
  • Receiving 1st cycle of 5 day Temodar
  • 136 Patients will be randomized 68 on each arm. Arm A: Emend + Zofran; Arm B: Zofran only
  • Emend is provided free by the study, Zofran is not provided by the study
  • Arm A: Emend 125mg day 1 and  80mg days 2-5 60 minutes prior to 1st 5 day 200mg/m2 Temo cycle 
  • Arm A & B: Zofran 8mg 30 minutes prior to 1st 5 day 200mg/m2 Temo cycle
  • Study lasts 5 weeks
  • Patient-Reported Outcomes will be assessed 7 times (baseline, and days 2-6) using MASCC and OSOBA surveys

Eligibility:

  • Histologically confirmed diagnosis of glioma (GBM, gliosarcoma or AA, or AO, oligodendroglioma) either chemotherapy naïve or non-naïve and scheduled to receive 1st cycle of 5 day Temo +/- Avastin
  • Age ≥ 18 years
  • ≤ 2 prior chemotherapeutic regimens
  • Receiving 1st cycle of Temozolomide at 200mg/m2 po X 5 days out of a 28 day cycle +/- Avastin
  • An interval of at least 6 weeks between prior surgical resection and 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
  • Corticosteroids, must be on a stable dose for 1 week prior to entry. Dexamethasone dose < 4 mg qd

Exclusion Criteria:

  • No prior nitrosourea (e.g. lomustine, carmustine)
  • Concurrent administration of CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs) including phenytoin, phenobarbitol, carbamazepine, oxcarbazepine or primidone
  • Received any drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent
  • Any vomiting, retching or NCI CTC v 4.0 grade 2-4 nausea 24 hours preceding chemotherapy
  • Ongoing vomiting from any organic etiology
  • Radiotherapy of cranium within one week prior to or during the study






This article comes from The Preston Robert Tisch Brain Tumor Center at Duke   http://www.cancer.duke.edu/btc
The URL for this story is:   http://www.cancer.duke.edu/btc/modules/ClinicalTrials4/index.php?id=116