Back to resultsStudy of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Capecitabine
Oxaliplatin
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
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 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.
Sites / Locations
- Queen Mary Hospital, The University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Xeloxiri
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate
Secondary Outcome Measures
Progression-free survival
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03146377
Brief Title
Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xeloxiri
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1250 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
85 mg/m2 IV on day 1 of a 2-week cycle
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
165 mg/m2 IV on day 1 of a 2-week cycle
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
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
Title
Overall survival
Time Frame
From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Yau, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer
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