Chemotherapy and targeted therapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials.
Florian Eckel, Roland M Schmid
https://pubmed.ncbi.nlm.nih.gov/25341559Actively Recruiting
Phase 2
Phase 3
Age: 18Years - 99Years
All Genders
ID05833815
A Randomized Controlled, Open Labeled, Two Arm Study of 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Gallbladder cancer is the most common and aggressive malignant tumor of the biliary tract, known for its very short median survival after diagnosis. Researchers are evaluating whether adding Everolimus, a drug that targets a key protein involved in cell growth and survival, to the standard treatment can improve outcomes for patients with advanced or inoperable gallbladder cancer. This study is a randomized controlled trial sponsored by Banaras Hindu University. Participants will be assigned to one of two groups: one will receive Everolimus 10 mg daily by mouth alongside standard chemotherapy treatments such as Gemcitabine and Oxaliplatin or Capecitabine and Oxaliplatin, while the other group will receive standard chemotherapy alone. The study is conducted in two phases and is open-label, meaning both doctors and participants know which treatment is given. During the study, participants will undergo regular assessments including monitoring of progression-free survival over 12 months, overall survival with 24 months follow-up, and tracking of chemotherapy side effects. Laboratory tests, imaging, and performance status evaluations will be used to follow health and treatment effects. Participants will be followed for safety and outcomes throughout the study period, which includes ongoing visits and evaluations to understand how the treatments affect their cancer and overall health.
CONDITIONS
Brief Title
Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histological proof of cancer with stage III inoperable or stage IV metastatic disease without prior treatment
- Patients with metastatic gallbladder carcinoma without previous treatment for metastasis or treated with gemcitabine/capecitabine with or without platinum at least 6 months ago
- Absolute neutrophil count (ANC) ≥ 1500/uL
- Platelet count ≥ 100,000/uL
- Total bilirubin ≤ 3 mg/dl for gemcitabine; any value for capecitabine
- ALT and AST ≤ 2.5 times upper limit of normal (ULN), ≤ 5 times ULN if liver metastases present
- Creatinine ≤ 1.5 times institutional ULN
- Alkaline phosphatase ≤ 5 times institutional ULN
- Hemoglobin ≥ 8.0 g/dL
- INR and PTT ≤ 3.0 times ULN; anticoagulation allowed if stable
- Fasting serum glucose < 1.5 times ULN
- ECOG Performance Status 0, 1, or 2
- Ability to provide informed consent
- Willingness to return for follow-up
- Life expectancy ≥ 12 weeks
- Women of childbearing potential must have negative serum pregnancy test within 7 days prior to registration
You will not qualify if you...
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Significant cardiac disease including recent myocardial infarction (≤ 6 months) or severe congestive heart failure (NYHA III or IV)
- Use of strong CYP3A4 inhibitors or inducers
- Prior therapy with Everolimus
- Receipt of chemotherapy, immunotherapy, biological therapy, or radiation therapy within 4 weeks prior to registration
- Radiation to more than 25% of bone marrow before registration
- Not fully recovered from prior chemotherapy effects
- Unstable brain or leptomeningeal metastases
- Pregnancy or nursing
- Unwillingness to use adequate contraception if of childbearing potential
- Other severe concurrent diseases or immunocompromised status (except corticosteroid use)
- Active other malignancies
- Gastrointestinal diseases affecting absorption of Everolimus
- Severely impaired lung function (FEV1 < 1 liter)
- Recent immunization with live vaccines or close contact with such individuals during treatment
- Severe liver disease (Child-Pugh class C) or active hepatitis B/C infection without proper assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 12 months
Participants receive oral Everolimus daily in addition to standard chemotherapy or standard chemotherapy alone to treat gallbladder cancer.
Regular treatment visits during chemotherapy cycles
Follow-up
Duration - Up to 24 months after treatment
Participants are monitored for overall survival and chemotherapy toxicity after completing treatment.
Periodic follow-up visits
Trial Site Locations
Total: 1 location
1
Banaras Hindu University
Varanasi, Uttar Pradesh, India, 221010
Actively Recruiting
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Research Team
M
Manoj Pandey
M
Madhumita Tripathi
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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Published Research Related To This Trial
Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer.
Juan Valle, Harpreet Wasan, Daniel H Palmer...
https://pubmed.ncbi.nlm.nih.gov/20375404Phase I pharmacokinetic and pharmacodynamic study of the oral mammalian target of rapamycin inhibitor everolimus in patients with advanced solid tumors.
Anne O'Donnell, Sandrine Faivre, Howard A Burris...
https://pubmed.ncbi.nlm.nih.gov/18332470Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study.
John N Primrose, Richard P Fox, Daniel H Palmer...
https://pubmed.ncbi.nlm.nih.gov/30922733SWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma.
Edgar Ben-Josef, Katherine A Guthrie, Anthony B El-Khoueiry...
https://pubmed.ncbi.nlm.nih.gov/25964250A phase II study of capecitabine and oxaliplatin combination chemotherapy in patients with inoperable adenocarcinoma of the gall bladder or biliary tract.
J S Graham, K Boyd, F Y Coxon...
https://pubmed.ncbi.nlm.nih.gov/26969121