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Gemcitabine for Biliary Cancers
Phase 1
Waitlist Available
Led By Jordan Kharofa, MD
Research Sponsored by Jordan Kharofa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Summary
Feasibility of neoadjuvant therapy in resectable biliary adenocarcinoma.
Eligible Conditions
- Biliary Cancers
- Bile Duct Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Completion of all therapy. Defined as completing 4/6 doses of gem/cis chemo, 80% of RT dose, and surgical resection.
Secondary outcome measures
Lymph node involvement. This will be measured by the Proportion of patients with involved lymph nodes (N0 vs N1).
Margin negative resection rate. This will be measured by the Proportion of patients with involved surgical margins (R1 rate).
Patients will be evaluated for toxicity during protocol therapy and postoperatively using the CTCAE v 5 criteria.
+3 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Ischaemic stroke
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Research TreatmentExperimental Treatment4 Interventions
Gemcitabine/Cisplatin/ChemoRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Fluorouracil
2014
Completed Phase 3
~11700
Find a Location
Who is running the clinical trial?
Jordan KharofaLead Sponsor
1 Previous Clinical Trials
14 Total Patients Enrolled
Jordan Kharofa, MDPrincipal Investigator - University of Cincinnati
University Radiology Associates, University of Cincinnati Medical Center
University Of Cincinnati College Of Medicine (Medical School)
1 Previous Clinical Trials
14 Total Patients Enrolled
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