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Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the DLT and the toxicity profile

Outcome Time Frame:

3 years

Safety Issue:

No

Authority:

Taiwan: Department of Health

Study ID:

PIST-CRC-01

NCT ID:

NCT00940758

Start Date:

June 2009

Completion Date:

June 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

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