Colorectal Cancer
Conditions
Keywords
metastases, neoplasm
Brief 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.
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.
Interventions
Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Diarrhea | eight weeks |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed