Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified
Conditions
Interventions
Intervention1: gemcitabin plus cisplatin plus Trastuzumab: -3 weekly gemcitabine (1000 mg/m2 IV on day 1 and day 8 q 3 weekly) plus cisplatin (25 mg/m2 IV on day 1 and day 8 q 3 weekly) plus
-3 weekl
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: histologically confirmed adenocarcinoma of the biliary tract, with the following specifications Biliary tract cancers including gallbladder cancer, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma HER2-positive by IHC or FISH (detailed later) ECOG performance status 0 - 1 Patient who can give informed consent for the study. Patient does not have any contraindications to receive chemotherapy, or trastuzumab Adequate hematological, hepatic and renal function parameters Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction ejection fraction equal or more than 50% or above lower limit of normal. ECG with no clinical relevant abnormalities 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. No major surgery within last 4 weeks written patient consent form
Exclusion criteria
Exclusion criteria: distal cholangiocarcinoma which would be considered as ampullary carcinomas Known hypersensitivity or contraindications against gemcitabine, cisplatin or trastuzumab clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV, Clinically 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 Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy Other severe internal disease or acute infection Baseline neuropathy more NCI Grade I Chronic inflammatory bowel disease Unhealed surgical wounds On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment Received any prior chemotherapy / radiotherapy or cancer directed therapy Any active ILD or history of lung illness requiring bronchodilator drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to estimate the median PFS % at 6 months with gemcitabine-cisplatin-trastuzumabTimepoint: 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| estimate the median -OS % at 6 months with gemcitabine-cisplatin-trastuzumab -comparing the tolerance of gemcitabine-cisplatin - trastuzumab -estimating the quality of life while on treatmentTimepoint: 60 months | — |
Countries
India
Contacts
Public ContactVikas Ostwal
Tata Memorial Hospital
Outcome results
None listed