Phase 1b Study of Gemcitabine and Leflunomide for Adults with Advanced Unresectable Pancreatic Cancer

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.

Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer