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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after completion of study treatment for reporting.

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 more

Trial 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

0 / 17Eligibility criteria met

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

~13 spots leftby Nov 2026

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