An Open-label, Single-centre, Single-arm Phase II Study of Triplet Combination of Capecitabine, Oxaliplatin and Irinotecan (Xeloxiri) as Salvage Therapy in Patients With Refractory Metastatic Colorectal Cancer

The University of Hong Kong1 site in 1 country32 target enrollmentApril 2014

ConditionsColorectal Cancer

InterventionsCapecitabine Oxaliplatin Irinotecan

DrugsCapecitabine Oxaliplatin Irinotecan

Overview

Phase: Phase 2
Intervention: Capecitabine
Conditions: Colorectal Cancer
Sponsor: The University of Hong Kong
Enrollment: 32
Locations: 1
Primary Endpoint: Objective response rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single centre, single-arm phase II study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (Xeloxiri regimen) in treating patients with refractory metastatic colorectal cancer. Clinical data from patients diagnosed with colorectal cancer will be collected and analyzed in this study. The patients' data will be collected and maintained in the Division of medical oncology of the Department of Medicine, Queen Mary Hospital.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

December 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The University of Hong Kong

Responsible Party

Principal Investigator

Dr. YAU Chung Cheung Thomas

Clinical Assistant Professor

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

•Adults ≥ 18 years of age, male or female.
•Histopathologically or cytologically confirmed adenocarcinoma.
•Failed ≥ 2 lines of standard therapy which must include a fluoropyrimidine, oxaliplatin and/or irinotecan, administered either as monotherapy or doublets.
•ECOG performance status 0 to
•Adequate bone marrow reserve.
•Absolute neutrophil count \> 1 × 109/L.
•Total bilirubin \< 3 × the upper limit of the normal range.
•Life expectancy ≥ 12 weeks.
•Signed written informed consent form.

Exclusion Criteria

•Prior malignant disease other than colorectal cancer within 5 years of study entry.
•Patients suitable for surgical or locoregional therapies.
•Patients unable to swallow oral medications.
•Any evidence of brain metastasis (unless the patient is \>6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
•Active clinically serious infections (\> grade 2 NCI / CTC Adverse Event version 3.0).
•History of allergy to platinum compounds.
•Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
•Patients who have severe bone marrow failure.
•Patients undergoing renal dialysis.
•History of HIV infection.

Arms & Interventions

Xeloxiri

Intervention: Capecitabine

Xeloxiri

Intervention: Oxaliplatin

Xeloxiri

Intervention: Irinotecan

Outcomes

Primary Outcomes

Objective response rate

Time Frame: Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months

Secondary Outcomes

Progression-free survival(From date of start until the date of first documented progression or death from disease-related causes or last follow-up, whichever came first, assessed up to 18 months)
Overall survival(From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months)