Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146377
• Other study ID #: MONC-LGI05
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2014
• Last updated: May 6, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine
1250 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
• Oxaliplatin
85 mg/m2 IV on day 1 of a 2-week cycle
• Irinotecan
165 mg/m2 IV on day 1 of a 2-week cycle

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate		Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months
Secondary	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
Secondary	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