Clinical trial NCT00940758: Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy
Official title: Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Colorectal Cancer
Lead sponsor: PharmaEngine
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment.


Eligibility criteria: 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)

Primary outcomes:
measure: To evaluate the DLT and the toxicity profile
timeFrame: 3 years
measure: To establish the MTD
timeFrame: 3 years
measure: To characterize the pharmacokinetics of biweekly PEP02 in patients with metastatic colorectal cancer who failed to first-line oxaliplatin-based chemotherapy
timeFrame: 3 years
Secondary outcomes:
measure: To collect data for preliminary evaluation of tumor response
timeFrame: 3 years
measure: To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References: