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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940758
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : April 6, 2017
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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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: PEP02 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : June 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: PEP02 Drug: PEP02
Dose escalation: 50-100 mg/m2 biweekly

Primary Outcome Measures :
  1. To evaluate the DLT and the toxicity profile [ Time Frame: 3 years ]
  2. To establish the MTD [ Time Frame: 3 years ]
  3. 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 Outcome Measures :
  1. To collect data for preliminary evaluation of tumor response [ Time Frame: 3 years ]
  2. To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00940758

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

Responsible Party: PharmaEngine Identifier: NCT00940758     History of Changes
Other Study ID Numbers: PIST-CRC-01
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents