A Randomized Controlled, Open Labeled, Two Arm, Study of Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
Gallbladder cancer (GBC) is the most common malignant tumour of the biliary tract. It is also the most aggressive cancer of the biliary tract with the shortest median survival from the time of diagnosis. Currently, radical resection is the most effective strategy to potentially cure GBC. Chemotherapy and radiotherapy have been employed as adjuvant and palliative setting, however, the overall survival is still dismal. This study aim to evaluate the addition of Everolimus in addition to standard of care in gallbladder cancer.
• Histological proof of cancer with stage III inoperable or Stage IV metastatic disease without any prior treatment.
• Patients with histologic proof of metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or who received gemcitabine/capecitabine with or without platinum\>= 6 months ago as part of adjuvant therapy
• Absolute neutrophil count (ANC) \>= 1500/uL
• Platelet (PLT) \>= 100,000/uL
• Total bilirubin =\< 3mg/dl for gemcitabine and any value for Capecitabine
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x upper limit of normal (ULN) (=\< 5x ULN in patients with liver metastases)
• Creatinine =\< 1.5 x Institutional ULN
• Alkaline phosphatase =\< 5 x Institutional ULN
• Haemoglobin (Hgb) \>= 8.0 g/dL
• International normalized ratio (INR) and Partial thromboplastin time (PTT) =\< 3.0 x ULN (anticoagulation is allowed if target INR =\< 3.0 x ULN on a stable dose of warfarin or on a stable dose of low-molecular-weight \[LMW\] heparin for \> 2 weeks at time of registration)
• Fasting serum glucose \< 1.5 x ULN
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
• Ability to provide informed consent
• Willingness to return for follow up
• Life expectancy \>= 12 weeks
• Women of childbearing potential only: Negative serum pregnancy test done =\< 7 days prior to registration.