Health Condition 1: C15-C26- Malignant neoplasms of digestive organs
Conditions
Interventions
Intervention1: Olanzapine, Aprepitant,IV Dexamethasone and Palanosetron: In control arm, the patients will receive 4 drug antiemetic regimen Olanzapine, Aprepitant,IV Dexamethasone and Palanosetron
C
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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 = 1. 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
Exclusion criteria
Exclusion criteria: 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. 8.The patient has taken or 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 chemotherapyTimepoint: during the 1st cycle of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 3.To compare the the dexamethasone free regimen to the control arm with respect to CR rates during pre-specified high MEC protocols for the second & third cycles of chemotherapy 4.To compare quality of life using FLIE questionnaire 5.To compare tolerance & side effects with both regimens 6.To assess the chemotherapy drug induced reactions & compare them in dexamethasone vs placebo arms.Timepoint: For 1 to 3 cycles of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Vikas Ostwal
Tata Memorial Hospital
Outcome results
None listed