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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940758
• Other study ID #: PIST-CRC-01
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2009
• Last updated: April 4, 2017
• Start date: June 2009
• Est. completion date: June 2014

Study information

• Verified date: April 2017
• Source: PharmaEngine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• PEP02
Dose escalation: 50-100 mg/m2 biweekly

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
PharmaEngine

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the DLT and the toxicity profile		3 years
Primary	To establish the MTD		3 years
Primary	To characterize the pharmacokinetics of biweekly PEP02 in patients with metastatic colorectal cancer who failed to first-line oxaliplatin-based chemotherapy		3 years
Secondary	To collect data for preliminary evaluation of tumor response		3 years
Secondary	To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity		3 years