Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT00755118
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed locally advanced or metastatic colorectal cancer
* Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
* ECOG performance status ≤ 2
* Age 18 - 72 years
* Patients who progress after 1st line therapy with FOLFOX/AVASTIN
* Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
* Patients must be able to understand the nature of this study
* Written informed consent
* Previous treatments with all effective drugs for metastatic colorectal cancer (CPT-11, LOHP, 5-FU/XELODA, Erbitux, Avastin)
Exclusion Criteria:
* History of serious cardiac disease (unstable angina, congestive heart failure,uncontrolled cardiac arrhythmias)
* History of myocardial infarction or stroke within 6 months
* Clinically significant peripheral vascular disease
* History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0
* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1
* Presence of central nervous system or brain metastases
* Evidence of bleeding diathesis or coagulopathy
* Blood pressure \> 150/100 mmHg
* Pregnant or lactating woman
* Life expectancy \< 3 months
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow
* Metastatic infiltration of the liver \>50%
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
* Active infection requiring antibiotics on Day 1
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Psychiatric illness or social situation that would preclude study compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
72 Years
Study:
NCT00755118
Study Brief:
Protocol Section:
NCT00755118