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Anti-metabolites
Gemcitabine + Leflunomide for Pancreatic Cancer
Phase 1
Recruiting
Led By Vincent Chung
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 1
Must not have
Clinically significant uncontrolled illness
Active infection requiring antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after completion of study treatment
Awards & highlights
Summary
This trial is testing whether combining leflunomide with gemcitabine is safe and effective in treating patients with advanced pancreatic cancer that cannot be surgically removed. The goal is to improve the
Who is the study for?
This trial is for patients with advanced pancreatic cancer that has spread and cannot be removed by surgery. Participants should not have had previous chemotherapy for metastatic disease and must have acceptable organ function.
What is being tested?
The trial is testing the safety, side effects, and best dose of leflunomide combined with gemcitabine. Leflunomide is usually used for rheumatoid arthritis but may help improve the effectiveness of gemcitabine in treating pancreatic cancer without increasing side effects.
What are the potential side effects?
Possible side effects include those typical of chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, liver issues from leflunomide, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can carry out all my usual activities without help.
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My liver enzyme AST levels are within the normal range.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am planning to receive gemcitabine as my only treatment.
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I have recovered from side effects of cancer treatment, except for hair loss or nerve issues.
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My liver enzyme (ALT) levels are within the normal range.
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My diagnosis is advanced pancreatic cancer that cannot be surgically removed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any uncontrolled serious illnesses.
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I am currently taking antibiotics for an infection.
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I have been diagnosed with Gilbert's disease.
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I am not taking any herbal medications except for CBD.
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I have trouble taking pills due to swallowing problems or constant nausea.
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I have tested positive for tuberculosis.
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I am currently experiencing diarrhea.
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I am not pregnant or breastfeeding.
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I have HIV or hepatitis but my viral load is undetectable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after completion of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after completion of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLTs)
Incidence of adverse events
Secondary outcome measures
Change in quality of life (QOL)
Overall response rate (ORR)
Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (gemcitabine, leflunomide)Experimental Treatment7 Interventions
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 of each cycle and leflunomide PO QD on days -3 to -1 prior to cycle 1 and days 1-28 of each cycle thereafter. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive cholestyramine PO TID for 11 days at the end of treatment in the absence of unacceptable toxicity. Patients also undergo CT, MRI, or other imaging scans as clinically indicated throughout the study, as well as blood sample collection on study and during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 3
~2020
Cholestyramine
2018
Completed Phase 4
~340
Computed Tomography
2017
Completed Phase 2
~2740
Gemcitabine
2017
Completed Phase 3
~1920
Leflunomide
2003
Completed Phase 4
~1670
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,518 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,870 Total Patients Enrolled
Vincent ChungPrincipal InvestigatorCity of Hope Medical Center
10 Previous Clinical Trials
409 Total Patients Enrolled
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