A randomized, placebo controlled, phase 3, triple blinded study to investigate the efficacy and tolerability of Olanzapine, Aprepitant,IV Dexamethasone and Palanosetron versus Olanzapine, Aprepitant,Palanosetron and palcebo in patients receiving moderately emetogenic chemotherapeutic (MEC) regimens (OMEC2)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 834
- 试验地点
- 1
- 主要终点
- The primary objective is to compare an antiemetic regimen consisting of aprepitant, palonosetron, dexamethasone and olanzapine (standard arm) and a regimen consisting of aprepitant, palonosetron, olanzapine, and placebo (experimental arm) with respect to complete response (CR) and the proportion of subjects with no vomiting,no significant nausea (scored as less than 5 on a scale of 1-100) and no use of rescue medications during pre-specified MEC protocols during the 1st cycle of chemotherapy
研究概览
简要总结
Chemotherapy often causes nausea and vomiting, which can be very upsetting. This affects how patients feel and their ability to stick to treatment. Minimizing these side effects improves patients’ lives. The main goal of the study is to compare two anti-nausea treatment plans. One includes aprepitant, palonosetron, dexamethasone, and olanzapine (standard), while the other substitutes dexamethasone with a placebo (experimental). We’re looking at how well each plan prevents vomiting, reduces nausea, and avoids extra medication during specific chemotherapy cycles. All patients screened will be listed on the "Screening list." Those meeting inclusion criteria and no exclusion criteria will be added to the "Inclusion list" and "Identification list" with a unique ID for the study. We need 834 patients for the study, grouped in blocks of four and randomly assigned one of the two treatment plan.Before starting chemotherapy on Day 1, patients will receive medication either with dexamethasone (Control arm) or placebo (Experimental arm) alongside other drugs. Olanzapine tablets will be taken the night before. On Days 2-3, patients will self-administer medications according to the given schedule. Patients will be contacted telephonically by the study team to report medication intake, vomiting episodes, and nausea levels. Mid-cycle evaluation (Day 7-10) post chemotherapy will include assessing medication intake, nausea/vomiting episodes, and completing questionnaires. End-of-cycle assessments will be done, and follow-up visits are required for study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients has a confirmed diagnosis of one of the cancers mentioned below i.Esophageal,gastro-esophageal and gastric cancers ii.Non-small cell cancers iii.Pancreatic cancers iv.Gallbladder cancers v.Small-bowel adenocarcinomas vi.Penile cancers vii.Urinary bladder transitional cell carcinomas viii.Colorectal cancer ix.Gynecological cancers and is receiving one of the mentioned chemotherapy protocols as below.
- •i.Modified FOLFIRINOX(every 2 weeks) ii.CAPIRI(every 3 weeks) iii.CAPOX(every 3 weeks) iv.Modified FOLFOX v.Pemetrexed plus Carboplatin(every 3 weeks) vi.GEMOX(Gemcitabine + Oxaliplatin)(every 2 weeks) vii.Gemcitabine plus carboplatin(3 Weekly) viii.Single Agent carboplatin (auc 5-7) 3 weekly regime ix.mDOF 2 weekly 2.The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
- •3.The patient is aged more than 18 years.
- •4.Patients should be chemotherapy naïve.
- •5.The patient has a WHO Performance Status of ≤
- •6.Hematologic and metabolic status must be adequate for receiving planned chemotherapy, and meet the following criteria: Total neutrophils more than 1500 per mm3 Platelets more than 100,000 per mm3 Bilirubin less than 1.5 times ULN(Upper Limits of Normal) Aspartate aminotransferase (AST)and or alanine aminotransferase (ALT) less than 3 into ULN GFR more than 50 ml per min 7.The patient or the attendant is able to read,understand,and complete questionnaires and daily components of the Patient Diary for each study cycle.
- •8.For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) or blood hCG results must be negative at screening.
- •9.Has a normal baseline ECG with no QTc prolongation.
排除标准
- •1.The patient and or attendant are unable to read, understand,and complete the forms required for the study.
- •2.The patient is pregnant or lactating.
- •3.The patient has experienced emesis (i.e.vomiting and/or retching) or clinically significant nausea (defined as nausea graded as moderate or severe) in the 24 hours preceding the first dose of study medication.
- •4.The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure,severe cognitive impairment, known central nervous system disease (e.g. brain metastases or a seizure disorder).
- •5.Hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the patient.
- •6.The patient has a known hypersensitivity or contraindication to palonosetron, another 5-HT3 receptor antagonist, dexamethasone, aprepitant or olanzapine.
- •7.The patient has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medications.Opiate drugs for cancer pain will be permitted if the patient has been on a stable dose and has not experienced emesis or clinically significant nausea from the narcotics in the 24 hours preceding the first dose of study medication.
- •This is inclusive of, but not limited to 5 HT3 antagonists, metoclopramide, benzodiazepines, phenothiazines, haloperidol, oral or intravenous steroids, antihistamines, domperidone, olanzapine, antipsychotics.
- •9.Patient on antipsychotics or being planned to receive any of the antiphychotics, amifostine in last 3 months.
- •10.Patient has received concurrent abdominal radiotherapy in last 3 months or being planned to receive the same.
- •11.Patient is receiving or will likely to receive concurrent use of quinolone antibiotic therapy.
- •12.Patient with the history of chronic alcoholism.
- •13.Patient with cardiac arrhythmia, uncontrolled/ controlled heart failure, or acute coronary event or uncontrolled diabetes mellitus within the previous 6 months.
- •14.Has taken drugs which may influence medications used in the study, e.g. CYP inducers or inhibitors.
- •This will have to be evaluated for and decision taken by PI.
结局指标
主要结局
The primary objective is to compare an antiemetic regimen consisting of aprepitant, palonosetron, dexamethasone and olanzapine (standard arm) and a regimen consisting of aprepitant, palonosetron, olanzapine, and placebo (experimental arm) with respect to complete response (CR) and the proportion of subjects with no vomiting,no significant nausea (scored as less than 5 on a scale of 1-100) and no use of rescue medications during pre-specified MEC protocols during the 1st cycle of chemotherapy
时间窗: during the 1st cycle of chemotherapy
次要结局
- 1.To compare the dexamethasone free regimen to the control arm with respect to no emesis rates(the proportion of subjects with no vomiting, & no use of rescue medications) during pre-specified high MEC protocols for 1 & 3 cycles of chemotherapy(2.To compare the dexamethasone free regimen to the control arm with respect to proportion of patients with no significant nausea(less than 5 on a score of 1-100)during pre-specified high MEC protocols for 1 to 3 cycles of chemotherapy)
研究者
Dr Vikas Ostwal
Tata Memorial Hospital