Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified
Conditions
Interventions
Intervention1: Multiagent chemotherapy: Gemcitabine nab Paclitaxel
Gemcitabine 1000 mg per m2 IV plus Nab paclitaxel 125 mg or m2 IVD1, D 8 and D15 q 28 days1 cycle equal to 28 days Start of next IV
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: . Histologically confirmed locally advanced unresectable or metastatic adenocarcinoma of the pancreas or ampulla, either by FNAC or biopsy of the primary site or metastatic site, with the following specifications ECOG PS 2 and age more than equal to 18 years OR - Age more than or equal to 70 years with G8 screening score risk. Adequate haematological, hepatic and renal function parameters. - Haematological- Hb > 80 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L. - Liver functions- bilirubin alkaline phosphatase = 2.5 g/L, -Renal function-estimated creatinine clearance >40 ml/min according to the CockcroftGault formula. - Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography - Women of childbearing age should have a negative urine pregnancy test or serum β-hcg at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial. -Willing to provide written informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the below criteria will be excluded from the study: -Patients with borderline resectable pancreatic cancer, resectable pancreatic cancers, orresectable ampullary cancers -Patients with known hypersensitivity or contraindications against gemcitabine, nabPaclitaxel, 5-FU,Capecitabine, Cisplatin or Oxaliplatin. -Patients with clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, significant valvular defect. -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 -Patients with severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. -Patients with baseline neuropathy more NCI Grade II -Patients with unhealed surgical wounds -Patients with uncontrolled co morbidities like diabetes (random blood sugar more than 200) and hypertension more than 140/90 mm hg) which are common at this age. -On treatment participation in another clinical study in the period 30 days before inclusion and during the study - Pregnant or breastfeeding women, or planning to become pregnant within 6 months after the end of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Progression free survival (PFS) -Disease control rates (DCR) and objective response rates (ORR) -Quality of life (QOL)Timepoint: 42 months | — |
Countries
India
Contacts
Public ContactSujay Srinivas
Tata Memorial Hospital
Outcome results
None listed