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 of leflunomide when given in combination with gemcitabine. II. To examine the relationship between pharmacokinetics and disease progression. OUTLINE: Patients receive gemcitabine intravenously (IV) over 30 minutes on days 1, 8, and 15 of each cycle and leflunomide orally (PO) once daily (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 three times a day (TID) for 11 days at the end of treatment in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), or other imaging scans as clinically indicated throughout the study, as well as blood sample collection on study and during follow up. After completion of study treatment, patients are followed up at 30 days then up to 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Undergo blood sample collection
Given PO
Undergo CT
Undergo imaging scans
Given IV
Given PO
Undergo MRI
City of Hope Medical Center
Duarte, California, United States
RECRUITINGDose 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)
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
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
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
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
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
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