This trial is active, not recruiting.

Condition metastatic colorectal cancer
Treatment pep02
Phase phase 1
Sponsor PharmaEngine
Start date June 2009
End date September 2011
Trial size 18 participants
Trial identifier NCT00940758, PIST-CRC-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Dose escalation: 50-100 mg/m2 biweekly

Primary Outcomes

To evaluate the DLT and the toxicity profile
time frame: 3 years
To establish the MTD
time frame: 3 years
To characterize the pharmacokinetics of biweekly PEP02 in patients with metastatic colorectal cancer who failed to first-line oxaliplatin-based chemotherapy
time frame: 3 years

Secondary Outcomes

To collect data for preliminary evaluation of tumor response
time frame: 3 years
To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by PharmaEngine.