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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaEngine
ClinicalTrials.gov Identifier:
NCT00940758
First received: July 15, 2009
Last updated: April 4, 2017
Last verified: April 2017
  Purpose
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: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by PharmaEngine:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 18
Actual Study Start Date: June 2009
Study Completion Date: June 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEP02 Drug: PEP02
Dose escalation: 50-100 mg/m2 biweekly

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  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 ClinicalTrials.gov identifier: NCT00940758

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

Responsible Party: PharmaEngine
ClinicalTrials.gov Identifier: NCT00940758     History of Changes
Other Study ID Numbers: PIST-CRC-01
Study First Received: July 15, 2009
Last Updated: April 4, 2017

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

ClinicalTrials.gov processed this record on June 26, 2017