Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05929885
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-04-24
Brief Title:
Metronomic Capecitabine Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Centre Singapore
Study Overview
Official Title:
A Phase II Study of Metronomic Capecitabine Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
Detailed Description:
Eligible patients will be recruited from the National Cancer Centre Singapore NCCS Patients will be referred for assessment by the primary physician to a study investigator for screening Informed written consent for entry into the trial will be obtained from the patient by a delegated investigator
All patients eligible for study entry will receive the LD-OXIRI regimen at the National Cancer Centre Singapore All concomitant medication taken during the study must be recorded If a drug is administered prophylactically this must be noted The patients will not receive any other investigational drugs while on this study
There will be a screening period of 28 days a treatment period till disease progression or unacceptable toxicity and a post-treatment follow up period of up to 24 months
All patients eligible for study entry will receive the LD-OXIRI regimen at the National Cancer Centre Singapore All concomitant medication taken during the study must be recorded If a drug is administered prophylactically this must be noted The patients will not receive any other investigational drugs while on this study
There will be a screening period of 28 days a treatment period till disease progression or unacceptable toxicity and a post-treatment follow up period of up to 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None