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Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer

ConditionsAdvanced Pancreatic AdenocarcinomaStage III Pancreatic Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Unresectable Pancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

This phase Ib trial tests the safety, side effects, and best dose of leflunomide in combination with gemcitabine in treating patients with pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and cannot be removed by surgery (unresectable). Improving the effectiveness of gemcitabine without increasing side effects could lead to a greater impact for pancreatic cancer patients' survival and quality of life. Gemcitabine is commonly used as a first-line chemotherapy treatment for pancreatic cancer. Leflunomide is a drug approved for use against rheumatoid arthritis that is being looked at as a cancer treatment option. It has shown promising results when combined with gemcitabine. Giving gemcitabine in combination with leflunomide may be safe and effective in treating patients with advanced unresectable pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented informed consent of the participant and/or legally authorized representative.

Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure oral medication compliance.

Agreement to allow the use of archival tissue from diagnostic tumor biopsies.

If unavailable, exceptions may be granted with study principal investigator (PI) approval.

Disqualifiers

Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.

Drugs metabolized by CYP2C8, CYP1A2, BCRP, OATP1B1/B3, and OAT3 transporters within 21 days prior to day 1 of protocol therapy.

Herbal medications (excluding cannabidiol [CBD]).

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Cholestyramine

    Drug

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Diagnostic Imaging

    Procedure/Surgery

    Undergo imaging scans

  • Gemcitabine

    Drug

    Given IV

  • Leflunomide

    Drug

    Given PO

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: Treatment (gemcitabine, leflunomide)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Dose limiting toxicities (DLTs)

Toxicities will be graded according to Common Terminology Criteria for Adverse Events version 5.0.

Time frame
Up to 28 days (cycle 1)
2

Incidence of adverse events

Toxicities will be graded according to Common Terminology Criteria for Adverse Events version 5.0.

Time frame
Up to 30 days after completion of study treatment

Secondary outcomes

1

Progression-free survival (PFS)

PFS will be estimated using the Kaplan-Meier product-limit method.

Time frame
From start of protocol treatment until progression or death, and if neither event occur, the patient is at the time of last contact, assessed up to 1 year after completion of study treatment
2

Overall survival (OS)

OS will be estimated using the Kaplan-Meier product limit method.

Time frame
From start of protocol treatment until death, and if the patient is alive, the patient is censored at time of last contact, assessed up to 1 year after completion of study treatment
3

Overall response rate (ORR)

ORR will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.

Time frame
Up to 1 year after completion of study treatment
4

Change in quality of life (QOL)

Change in QOL will be measured by the Functional Assessment of Cancer Therapy: General (FACT-G) questionnaire.

Time frame
Baseline to 1 year after completion of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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