Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: irinotecan, capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wXELIRI regimen<br> | Drug: irinotecan, capecitabine<br>* Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Diarrhea |  | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | eight weeks | 
| Response rate |  | eight weeks | 
| Disease control rate |  | eight weeks | 
| Overall survival |  | eight weeks | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastases, neoplasm