Colorectal CancerPhase 2NCT03146377
Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal Cancer
A Phase 2 study testing Capecitabine, Oxaliplatin and Irinotecan in people with Colorectal Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Capecitabine, Oxaliplatin and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Total bilirubin < 3 × the upper limit of the normal range.
- Life expectancy ≥ 12 weeks.
- Signed written informed consent form.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Capecitabine, Oxaliplatin, Irinotecan
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
1250 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
OxaliplatinDrug
85 mg/m2 IV on day 1 of a 2-week cycle
IrinotecanDrug
165 mg/m2 IV on day 1 of a 2-week cycle
| Study group | Role | What they receive |
|---|---|---|
| Xeloxiri | Experimental | Not described Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months
Secondary outcomes (2)
Progression-free survival
Measured: 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
Measured: From date of start until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. YAU Chung Cheung Thomas, The University of Hong Kong
- Investigators
- Thomas Yau, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146377
- Sponsor's protocol ID
- MONC-LGI05
- Status last verified
- May 2017
- First submitted
- 6 May 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03146377
- Acronym / sponsor ID
- MONC-LGI05
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xeloxiri | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Drug: Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: Xeloda1250 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off) | Drug | Xeloxiri |
| Oxaliplatin85 mg/m2 IV on day 1 of a 2-week cycle | Drug | Xeloxiri |
| Irinotecan165 mg/m2 IV on day 1 of a 2-week cycle | Drug | Xeloxiri |
Primary outcome
Objective response rate
Time frame: Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Yau, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Oxaliplatin and Irinotecan in people with Colorectal Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Change from baseline in size approximately every 8 weeks (4 cycles), up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.