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OXIRI [Oxaliplatin (O), Xeloda (X) and Irinotecan (I)] in Pancreatic Adenocarcinoma

NCT02368860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-06-01

No results posted yet for this study

Summary

This is an exploratory Phase I study is to assess the safety and tolerability of the OXIRI regimen \[oxaliplatin (O), xeloda (X) and irinotecan (I)\] and to evaluate for preliminary evidence of efficacy, in patients with advanced and/or metastatic pancreatic adenocarcinoma. The investigators hypothesize that 2 of 3 weekly doses of oxaliplatin and genotype directed-dosing of irinotecan in combination with chronomodulated capecitabine (xeloda) administered continuously will be more tolerable than the FOLFIRINOX regimen (folinic acid, fluorouracil, irinotecan and oxaliplatin) while maintaining anti-tumour activity.

Conditions

Interventions

DRUG

oxaliplatin, irinotecan, capecitabine

fixed doses of intravenous oxaliplatin 50 mg/m2, and intravenous irinotecan administered on days 1 and 8 in a 21 day-cycle while xeloda will be administered daily at around midnight from day 1 to day 14

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Matthew CH Ng, Dr · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-17
Primary Completion
2020-05-21
Completion
2020-05-21

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02368860 on ClinicalTrials.gov