Actively Recruiting
Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
Led by Banaras Hindu University · Updated on 2024-08-13
56
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological proof of stage III inoperable or stage IV metastatic gallbladder cancer without prior treatment for metastatic disease
- Patients with metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or received gemcitabine/capecitabine with or without platinum at least 6 months ago as adjuvant therapy
- Absolute neutrophil count of 1500/uL or higher
- Platelet count of 100,000/uL or higher
- Total bilirubin 3 mg/dl or less for gemcitabine treatment; any value allowed for capecitabine
- ALT and AST levels 2.5 times or less the upper limit of normal (up to 5 times if liver metastases present)
- Creatinine 1.5 times or less the institutional upper limit of normal
- Alkaline phosphatase 5 times or less the institutional upper limit of normal
- Hemoglobin level of 8.0 g/dL or higher
- INR and PTT 3.0 times or less the upper limit of normal; anticoagulation allowed if stable and within target INR
- Fasting serum glucose less than 1.5 times the upper limit of normal
- ECOG performance status of 0, 1, or 2
- Ability to provide informed consent
- Willingness to return for follow-up
- Life expectancy of at least 12 weeks
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to registration
You will not qualify if you...
- Uncontrolled illnesses including active infections, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting study compliance
- Significant cardiac disease such as recent myocardial infarction (within 6 months) or severe congestive heart failure requiring ongoing treatment
- Use of strong CYP3A4 inhibitors or inducers
- Prior therapy with everolimus
- Chemotherapy, immunotherapy, biological therapy, or radiation therapy within 4 weeks prior to registration
- Radiation to more than 25% of bone marrow before registration
- Incomplete recovery from acute effects of prior chemotherapy
- Unstable brain or leptomeningeal metastases within 4 weeks prior to registration
- Pregnancy or nursing
- Unwillingness to use adequate contraception if of childbearing potential
- Concurrent investigational therapies
- Severe systemic illnesses or diseases interfering with safety assessment
- Immunocompromised status excluding corticosteroid use, including HIV positive
- Active other cancers
- Gastrointestinal disorders affecting everolimus absorption
- Severely impaired lung function (FEV1 less than 1 liter)
- Recent live attenuated vaccinations (within 7 days) or close contact with vaccinated individuals
- Severe liver disease such as cirrhosis or Child-Pugh class C
- Positive hepatitis B or C virus DNA/RNA without proper assessment and management
AI-Screening
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Trial Site Locations
Total: 1 location
1
Banaras Hindu University
Varanasi, Uttar Pradesh, India, 221010
Actively Recruiting
Research Team
M
Manoj Pandey
CONTACT
M
Madhumita Tripathi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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