City of Hope Medical Center
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.
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of gemcitabine in combination with leflunomide and determine the recommended Phase 2 dose (RP2D) of the combination. SECONDARY OBJECTIVES: I. To evaluate the progression-free (PFS) and overall survival (OS). II. To evaluate the overall response rate (ORR), including confirmed and unconfirmed, complete and partial response and stable disease. III. To describe quality of life utilizing the Functional Assessment of Cancer Therapy: General (FACT-G) questionnaire. EXPLORATORY OBJECTIVES: I. To describe the pharmacokinetic profile o…
Inclusion Criteria: * 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. * Age: ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) ≤ 1. * Subjects must have histologically or cytologically confirmed diagnosis of advanced unresectable pancreatic…
Undergo blood sample collection
Given PO
Undergo CT
Undergo imaging scans
Given IV
Given PO
Undergo MRI
Arctuva estimate
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