Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Everolimus 10 mg

    Drug

    Oral Everolimus 10 mg daily in addition to standard of care i.e. GemOx or CapOx

  • Standard of care

    Drug

    GemOx or CapOx

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Additional EverolimusExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

Progression free survival from diagnosis to disease progression or death

Time frame
12 months

Secondary outcomes

1

Overall survival

Survival time from the enrollment till the study closure

Time frame
24 months followup
2

Chemotherapy Toxicity

Toxicity of addition of Everolimus to standard of care as measured by WHO toxicity criteria

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Banaras Hindu University

Lead sponsor

Source ClinicalTrials.gov
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