Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
ConditionGallbladder Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBanaras Hindu University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Clinically significant cardiac disease, especially history of myocardial infarction =< 6 months, or congestive heart failure (New York Heart Association [NYHA] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Patients taking strong inhibitors or inducers of CYP3A4
Prior therapy with everolimus
Trial design
Treatments tested in this trial
- Everolimus 10 mg
- Standard of care
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov