Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy
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)