Colorectal CancerPhase 2NCT01322152
Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer
A Phase 2 study testing irinotecan, capecitabine in people with Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- irinotecan, capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Jun 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Histologically confirmed colorectal cancer
- Age 18-70 years old
- Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
- Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- ECOG 0-1
- Life expectancy of more than 3 months.
- Normal laboratory values: hemoglobin > 90g/dl, neutrophils > 1.5×10^9/L, platelets > 100×10^9/L, serum creatinine < 1.5×upper limit of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN, AKP < 4×ULN
Who cannot join
- Pregnant or lactating patients
- Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
- Active or uncontrolled infection
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
- Patients could not swallow the tablets
- Concomitant with brain metastases
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients
The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.
Read the detailed description
Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.
- Conditions
- Colorectal Cancer
- Being tested
- irinotecan, capecitabine
- Keywords
- metastases, neoplasm
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecan, capecitabineDrug
Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.
| Study group | Role | What they receive |
|---|---|---|
| wXELIRI regimen | Experimental | Not described Receives: Drug: irinotecan, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Diarrhea
Measured: eight weeks
Secondary outcomes (5)
Progression free survival
Measured: eight weeks
Response rate
Measured: eight weeks
Disease control rate
Measured: eight weeks
Overall survival
Measured: eight weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Li, Fudan University
- Investigators
- Jin Li, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322152
- Sponsor's protocol ID
- XELIRIcrc
- Status last verified
- Jun 2013
- First submitted
- 23 Mar 2011
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li W, Xu J, Shen L, Liu T, Guo W, Zhang W, Chen Z, Zhu X, Li J. Phase II study of weekly irinotecan and capecitabine treatment in metastatic colorectal cancer patients. BMC Cancer. 2014 Dec 19;14:986. doi: 10.1186/1471-2407-14-986.
PubMed 25527007
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT01322152
- Acronym / sponsor ID
- XELIRIcrc
- Conditions
- Colorectal Cancer
- Keywords
- metastases, neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Mar 2011 (estimated)
- 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.
The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.
Detailed description
Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wXELIRI regimen | Experimental | Drug: irinotecan, capecitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Histologically confirmed colorectal cancer
- Age 18-70 years old
- Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
- Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Key exclusion criteria (6 listed)
- Pregnant or lactating patients
- Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
- Active or uncontrolled infection
- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
- Patients could not swallow the tablets
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 |
|---|---|---|
| irinotecan, capecitabineIrinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days. | Drug | wXELIRI regimen |
Primary outcome
Rate of Diarrhea
Time frame: eight weeks
5 secondary outcomes
Progression free survival
Time frame: eight weeks
Response rate
Time frame: eight weeks
Disease control rate
Time frame: eight weeks
Overall survival
Time frame: eight weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: eight weeks
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 11 Jun 2013.
- Derived from this study: PubMed 25527007Li W, Xu J, Shen L, Liu T, Guo W, Zhang W, Chen Z, Zhu X, Li J. Phase II study of weekly irinotecan and capecitabine treatment in metastatic colorectal cancer patients. BMC Cancer. 2014 Dec 19;14:986. doi: 10.1186/1471-2407-14-986.
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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.
Jin Li, PhD principal investigator
Fudan University
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 irinotecan, capecitabine in people with Colorectal Cancer, run by Fudan University at 1 site in China.
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 8 inclusion and 6 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 11 Jun 2013. 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 China. 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?
Rate of Diarrhea (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322152, which also lists 1 linked publication.
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 11 Jun 2013.