Clinical trial NCT01322152: Study of Irinotecan Plus Capecitabine to Treat Advanced Colorectal Cancer
Official title: Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: metastases
neoplasm
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Diarrhea
timeFrame: eight weeks
Secondary outcomes:
measure: Progression free survival
timeFrame: eight weeks
measure: Response rate
timeFrame: eight weeks
measure: Disease control rate
timeFrame: eight weeks
measure: Overall survival
timeFrame: eight weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: eight weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.