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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by PharmaEngine.
Recruitment status was  Active, not recruiting
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PharmaEngine Identifier:
First received: July 15, 2009
Last updated: March 1, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: PEP02
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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Further study details as provided by PharmaEngine:

Primary Outcome Measures:
  • To evaluate the DLT and the toxicity profile [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To establish the MTD [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To collect data for preliminary evaluation of tumor response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEP02 Drug: PEP02
Dose escalation: 50-100 mg/m2 biweekly


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00940758

National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
  More Information

Responsible Party: Jang-Yang Chang, National Health Research Institutes Identifier: NCT00940758     History of Changes
Other Study ID Numbers: PIST-CRC-01 
Study First Received: July 15, 2009
Last Updated: March 1, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on May 26, 2016