Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Irinotecan

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, The University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 2.
• 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.
• Seizure disorder requiring medication (such as steroids or anti-epileptics).
• Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xeloxiri	Drug: Capecitabine; 1250 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off); Other Names: Xeloda; Drug: Oxaliplatin; 85 mg/m2 IV on day 1 of a 2-week cycle; Drug: Irinotecan; 165 mg/m2 IV on day 1 of a 2-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate	Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Capecitabine; Oxaliplatin; Irinotecan
• Other Study ID Numbers: MONC-LGI05