Health Condition 1: K828- Other specified diseases of gallbladder
Conditions
Interventions
Intervention1: TAB CAPECITABINE
INJ OXALIPLATIN
INJ IRINOTECAN: TAB CAPECITABINE 1000MG/M2 PO WITH FOOD FROM DAY 1 TO DAY 7, F/B 7 DAYS OFF
INJ OXALIPLATIN (85 MG/M2) IN 500ML 5% DEXTROSE IV OVER 2
Sponsors
DR MAHESH KOULAGI
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histologically proven cases of adenocarcinoma of the gallbladder, which are locally advanced, unresectable or metastatic 2)Eastern Cooperative Oncology Group performance status greater than18 or equal to 1 3)age greater than18 years 4)Adequate bone marrow functions reflected as Hb greater than 10 g/dL, Total 5)leucocytes count greater than 4,000/mm3 (ANC greater than 1,500/mm3), and platelets greater than 1,00,000/mm3 6)Creatinine clearance greater than 45 mL/min 7)serum bilirubin less than 3 mg/dl and Hepatic transaminases SGOT & SGPT within three times ULN 8)Chemotherapy na ve (no prior systemic chemotherapy)
Exclusion criteria
Exclusion criteria: 1)Presence of an active, uncontrolled documented infection 2)Lactating and pregnant women 3)Patients who are on other investigational drugs 4)Patients with uncontrolled diabetes mellitus, HBa1c greater than 10, RBS greater than 250 5)Know allergy or hypersensitivity to study drugs 6)Patient who refuses to give consent 7)Known deficiency of dihydropyrimidine dehydrogenase enzyme and UGT1A1 polymorphisms 8)Inability to take oral medications 9)Decompensated, cardiac, pulmonary, renal, immunological disease, psychiatric illness, active tuberculosis and those seropositive for HIV, HBV and HCV and not on treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ORRTimepoint: Assessment will be done at baseline, after 8 weeks, 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Progression free survival Disease control dateTimepoint: Safety will be assessed every 2 weeks | — |
Countries
India
Contacts
Public ContactDr Deepak Sundriyal
AIIMS RISHIKESH
Outcome results
None listed