RecruitingPhase 2NCT05929885

Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients

A Phase II Study of Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients.

Sponsor

National Cancer Centre, Singapore

Enrollment

50 participants

Start Date

Aug 30, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Cancer

Summary

This is a single-centre, non-randomized, open label phase II trial to be conducted at the National Cancer Centre, Singapore (NCCS). Patients diagnosed with metastatic PDAC will be eligible to enrol. The investigators hypothesize the anticancer activity of low dose OXIRI (LD-OXIRI) regimen comprising of metronomic oxaliplatin (O) and metronomic capecitabine (xeloda; X) in combination with UGT1A1-directed dosing of irinotecan (IRI) to be a tolerable regimen in patients with advanced PDAC and will lead to a favourable response rate. Patients will be prospectively enrolled in two stages - In stage 1, patients will be recruited and evaluated for response and toxicity. In stage 2, more patients will be recruited for further evaluation of response and toxicity.

Eligibility

Min Age: 21 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests a low-dose (metronomic) chemotherapy combination — capecitabine, oxaliplatin, and irinotecan (with the irinotecan dose tailored to your genetics) — as a treatment for advanced or metastatic pancreatic cancer. **You may be eligible if...** - You are over 21 with confirmed pancreatic cancer that cannot be surgically removed - You have at least one measurable tumor on imaging - Your general health score (ECOG) is 0 to 2 - Your blood counts, liver, and kidney function meet the required thresholds - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have another cancer diagnosis within the last 5 years - You have untreated cancer spread to the brain - You have had chemotherapy or radiotherapy within the past 4 weeks - You have had major surgery in the past 2 weeks - You are on immunosuppressive therapy - You are pregnant or breastfeeding - You are taking blood thinners (vitamin K antagonists like warfarin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLow Dose OXIRI (LD-OXIRI)

The LD-OXIRI regimen will be administered in the following sequence: * metronomic capecitabine (Xeloda; X) 650mg/m2 will administered twice a day on a daily a continuous basis; * intravenous metronomic oxaliplatin (O) 50 mg/m2 will be infused over 120 minutes on days 1 and 8 of a 21 day-cycle; followed by * intravenous irinotecan (I) will be infused over 90 minutes on days 1 and 8 of a 21 day-cycle. The dose of irinotecan will be based on the particular patient's UGT1A1\*6 and UGT1A1\*28 genotype status.