Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy

Inclusion Criteria:

* Histopathologically confirmed metastatic colorectal cancer
* Documented disease progression after first-line chemotherapy containing oxaliplatin
* Both genders, age 18 years
* ECOG performance status 0 or 1
* Adequate organ and marrow function
* Written informed consent to participate in the study

Exclusion Criteria:

* Have received irinotecan treatment
* With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
* With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea \> grade 1)
* With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
* With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment.
* Prior chemotherapy within 3 weeks
* Major surgery or radiotherapy within 4 weeks
* Prior participation in any investigational drug study within 3 weeks
* History of allergic reaction to liposome product
* Pregnant or breastfeeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)