/NCT05929885

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

Trial number:: NCT05929885

Trial phase:: 2

Study type:: Any

Overall status:: Not yet recruiting

Study start date

August, 2023

Scientific title

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

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.

The patient must meet all of the inclusion criteria to participate in the study.

Aged above 21Histopathological diagnosis of pancreatic cancer Advanced disease not amenable to curative resection (locally advanced or metastatic disease) Measureable disease by RECIST 1.1 criteria Life expectancy of at least 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Adequate hematologic function (granulocyte count ≥ 1.5 × 10**9/L, platelet count ≥ 100 × 10**9/L), Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal [ULN], AST and ALT, ALP ≤ 3 x ULN or < 5 x ULN in case of hepatic involvement), Adequate renal function (creatinine clearance > 50 mL/min) will be eligible for inclusion into the study. Able to provide written and informed consent

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Intervention model description: 43 patients will be enrolled in two stages - In stage 1, a total of 19 patients will be recruited and evaluated for response and toxicity. In stage 2, another 24 patients will be recruited for further evaluation of response and toxicity. Up to 7 patients will be recruited to account for any drop outs (i.e. up to total of 50 patients)., Masking: None (Open Label),

Conditions

Metastatic Pancreatic Cancer

Other study ID numbers

LDOXIRI-PDAC-01

Choose trial site (1)

National Cancer Centre Singapore

30 Hospital Blvd, Singapore 168583