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.
Drug: irinotecan, capecitabine
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Locations near you
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Full eligibility criteria for NCT01322152
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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
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
All locations for NCT01322152
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China
View full eligibility
Tris trial is registered with FDA with number: NCT01322152. The sponsor of the trial is Fudan University and it is looking for 52 volunteers for the current phase.
Official trial title: Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients
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