Actively Recruiting
A Phase 1b Study of Gemcitabine and Leflunomide in Patients With Unresectable Pancreatic Cancer
Led by City of Hope Medical Center · Updated on 2026-04-13
19
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of leflunomide combined with gemcitabine in treating patients with advanced pancreatic cancer that cannot be removed by surgery. This phase Ib trial aims to improve the effectiveness of gemcitabine, a common chemotherapy drug, without increasing side effects, potentially benefiting survival and quality of life. Leflunomide, normally used for rheumatoid arthritis, is being studied for its cancer treatment potential when combined with gemcitabine. Participants receive gemcitabine intravenously on days 1, 8, and 15 of each 28-day cycle, and leflunomide orally once daily starting three days before the first cycle and continuing daily during each cycle. Treatment cycles repeat every 28 days unless the disease progresses or unacceptable side effects occur. At the end of treatment, participants may take cholestyramine orally three times daily for 11 days if tolerated. Imaging scans such as CT or MRI and blood sample collections are performed during the study as needed. Participants are closely monitored for side effects and response to treatment throughout the study and for up to one year after completing treatment. Researchers assess dose-limiting toxicities and adverse events up to 30 days after treatment ends. They also evaluate progression-free survival, overall survival, response rates, and quality of life using questionnaires over one year. Follow-up visits occur 30 days after treatment and continue up to one year to track long-term outcomes.
CONDITIONS
Brief Title
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent or have a legally authorized representative consent on your behalf.
- Adult aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed diagnosis of advanced unresectable pancreatic ductal adenocarcinoma.
- Measurable or evaluable disease by RECIST version 1.1.
- Planned to receive single agent gemcitabine treatment.
- Fully recovered from prior anti-cancer therapy side effects except alopecia or neuropathy (grade 1 or less).
- Adequate blood counts and organ function as specified (ANC ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 9g/dL, bilirubin, AST, ALT, and creatinine within specified limits).
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control or abstain during the study and for specified periods after treatment.
- Men of childbearing potential must agree to use effective birth control or abstain during the study and for specified periods after treatment.
- Agreement to allow use of archival tissue from diagnostic tumor biopsies or obtain study investigator approval if unavailable.
- If lacking consent capacity, have a caretaker to ensure oral medication compliance.
You will not qualify if you...
- Received chemotherapy, radiation, biological therapy, or immunotherapy within 21 days before starting the study treatment.
- Use of drugs metabolized by certain enzymes or transporters within 21 days prior to treatment.
- Use of herbal medications except cannabidiol (CBD).
- History of allergic reactions to similar compounds as study drugs.
- Difficulty tolerating oral medication, including swallowing or malabsorption issues.
- Active or latent tuberculosis infection.
- Active diarrhea.
- Clinically significant uncontrolled illness.
- Active infection requiring antibiotics.
- Known HIV, hepatitis B, or hepatitis C infection unless viral load is undetectable.
- Diagnosis of Gilbert's disease.
- Prior malignancy unless treated and disease-free for 5 or more years, with some exceptions.
- Pregnant or breastfeeding women.
- Any condition that may contraindicate participation due to safety concerns.
- Inability to comply with study procedures or logistics as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive gemcitabine intravenously on days 1, 8, and 15 and take leflunomide orally daily from 3 days before cycle 1 through each 28-day cycle. Treatment cycles repeat every 28 days until disease progression or unacceptable toxicity. Participants also take cholestyramine orally three times daily for 11 days after treatment ends if tolerated. Imaging scans and blood samples are collected as clinically indicated throughout treatment.
3 visits per cycle for gemcitabine infusion, daily oral medication, and imaging as needed
Duration - Up to 1 year after treatment ends
After completing treatment, participants are followed for safety and survival outcomes with visits occurring up to 1 year.
1 visit at 30 days post-treatment and periodic visits up to 1 year
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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