Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer

NCT03146377 | Completed Phase 2

• 1 other identifier: MONC-LGI05
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

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

Secondary Outcomes (2)

• 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

Study Arms (1)

Xeloxiri

EXPERIMENTAL

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Irinotecan

Interventions

Capecitabine DRUG

1250 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)

Also known as: Xeloda

Xeloxiri

Oxaliplatin DRUG

85 mg/m2 IV on day 1 of a 2-week cycle

Xeloxiri

Irinotecan DRUG

165 mg/m2 IV on day 1 of a 2-week cycle

Xeloxiri

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Thomas Yau, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 9, 2017
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

HK (1)