Health Condition 1: K868- Other specified diseases of pancreas
Conditions
Interventions
Intervention1: LOSARTAN: Arm B â?? chemotherapy alone Oxaliplatin 65mg/m2 IV over 2 hours Irinotecan 135mg/m2 IV over 90 mins Leucovorin 300mg/m2 IV over 2 hours
5 FU - 1800mg/m2 IV over 46 hours cont
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria : 1. Histologically confirmed adenocarcinoma of the pancreas or ampulla, either by FNAC or biopsy of primary site or metastatic site, with the following specifications a. For pancreatic adenocarcinoma - either locally advanced pancreatic cancer (unresectable) or metastatic pancreatic cancer, as per NCCN criteria, 2019 b. For ampullary adenocarcinoma - metastatic adenocarcinoma alone 2. Age 18 to 75 years. 3. ECOG performance status 0 - 1 4. Patient who can give informed consent for the study. 5. Patient does not have any contraindications to receive chemotherapy, or Losartan 6.Adequate hematological, hepatic and renal function parameters· 7. Systolic Blood pressure > 100mm Hg ( 2 separate readings) 8. Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography 9. Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial. 10. No major surgery within last 4 weeks 11. written patient consent form
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Borderline resectable pancreatic cancer, resectable pancreatic cancers, or resectable ampullary cancers 2.Known hypersensitivity or contraindications against drugs used in the FOLFIRINOX regimen or Losartan 3.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA II-IV, 4.Clinically significant valvular defect 5.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix 6.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy 7.Other severe internal disease or acute infection 8.Baseline neuropathy > NCI Grade II 9.Chronic inflammatory bowel disease 10.Unhealed surgical wounds 11. Severe hemorrhage 12.Recent hemoptysis 13.History of GI perforation 14.Uncontrolled hypertension 15. Severe/arterial thromboembolism 16.Bilateral renal Artery stenosis 17.On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study 18.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether the addition of a drug commonly used in control of blood pressure (Losartan) will improve survival when combined with standard chemotherapy in advanced pancreatic and periampullary cancersTimepoint: 84 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To check overall survival without recurrence of disease 2. To check Response rates towards different regimens 3.Side effects that will occur 4.Quality of life analysis Timepoint: 84 months | — |
Countries
India
Contacts
Public ContactDr Anant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed