Efficacy of olanzapine based, dexamethasone free anti emetic strategy in chemotherapy naive patients planned to receive oxaliplatin based moderately emetogenic chemotherapy: an open label single arm phase II trial

CI0 个研究点目标入组 82 人开始时间: 待定最近更新: 2023年2月6日

试验速览

暂无简介。

•Diagnosis of malignancy
•No prior chemotherapy and radiation therapy (RT)
•Age of >= 18 â?? up to 65 years
•ECOG Performance status (0-2)
•Complete hemogram (ANC >=1000/m3, TLC >=3000/m3, Platelets >= 1,00,000/m3), Creatinine (<= 2 mg/dl), SGOT / SGPT (<= 3 X ULN, Bilirubin <2.0 mg/dl)
•First cycle of moderately emetogenic chemotherapy defined as
•Oxaliplatin at dose >=80mg/m2 with or without other agents
•Willing to give written informed consent for the study participation

•Patient receiving concurrent psychiatric drugs (clozapine, risperidone, quetiapine, phenothiazine etc), CNS depressants (azelastine, bromopride, bromperidol, buprenorphine), anti-Parkinson drugs (dopamine agonist), benzodiazepines, cabergoline, anti-cholinergic (glycopyrrolate, ipratropium, levosulpiride, potassium chloride, potassium citrate etc), metoclopramide, pimozide, quinolone, amifostine
•Hypersensitivity to any of the drugs used in the study {Olanzapine, 5-HT3 antagonist â?? Ondansetron}
•On systemic steroids
•History of any uncontrolled systemic disease including hypertension, thyroid, CNS, renal, CHF and MI in last 6 months and requiring hemodialysis
•Symptomatic Brain metastasis / Carcinomatous Meningitis
•History of nausea and vomiting in 24 hours prior to first dose of chemotherapy
•Use of anti-emetic drugs (5-HT3 Antagonist) in last 24 hours
•Started on opioids in last 48 hours
•Female who is pregnant, or breast-feeding his children
•Patients with dementia related psychosis or psychiatric disorder
•No concurrent abdominal radiotherapy

发起方