Health Condition 1: C15-C26- Malignant neoplasms of digestive organs Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx Health Condition 3: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs Health Condition 4: C64-C68- Malignant neoplasms of urinary tract
Conditions
Interventions
Intervention1: 4 drug antiemetic regimen include drugs
aprepitant, palonosetron,Dexamethasone,
olanzipine: Day 1
60 mins before chemotherapy,
capsule aprepitant 125 mg PO plus
palonosetron 0.25mg IV
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients has a confirmed diagnosis of one of the cancers mentioned previously and is receiving one of the mentioned chemotherapy protocols mentioned previously. 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 > 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 >= 1500/mm3 Platelets >= 100,000/mm3 Bilirubin Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) GFR >= 50 ml/min 7. The patient 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
Exclusion criteria
Exclusion criteria: 1.The patient is 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/ 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 received an investigational drug in the previous 6 months or is scheduled to receive any investigational drug other than fosaprepitant dimeglumine during the study period 8.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. 9.The patient has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drugs. This is inclusive of, but not limited to 5 HT3 antagonists, metoclopramide, benzodiazepines, phenothiazines, haloperidol, oral or intravenous steroids, antihistamines, domperidone, olanzapine, antipsychotics. 10.Patient on antipsychotics or being planned to receive any of the antiphychotics, amifostine in last 3 months. 11.Patient has received concurrent abdominal radiotherapy in last 3 months or being planned to receive the same. 12.Patient is receieving or will likey to receive concurrent use of quinolone antibiotic therapy. 13.Patient with the history of chronic alcoholism. 14.Patient with cardiac arrhythmia, uncontrolled/ controlled heart failure, or acute coronary event or uncontrolled diabetes mellitus within the previous 6 months. 15.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objectives The primary objective is to compare an antiemetic regimen consisting of aprepitant, palonosetron, dexamethasone and olanzapine (active arm) and a regimen consisting of aprepitant, palonosetron, and dexamethasone, (control arm) with respect to complete response (CR); the proportion of subjects with no vomiting, no significant nausea (scored as 5 on a scale of 1-100) and no use of rescue medications during pre-specified high MEC protocols for 1 cycle of chemotherapyTimepoint: 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the olanzapine containing regimen to the control arm with respect to no emesis rates 2.to compare the olanzapine containing regimen to the control arm with respect to proportion of patients with no significant nausea 3.olanzapine containing regimen to the control arm with respect to CR rates 4.FLIE questionnaire 5.tolerance and side effects with both regimensTimepoint: 42 months | — |
Countries
India
Contacts
Public ContactVikas ostwal
Tata Memorial Hospital
Outcome results
None listed