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:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT00493857
Eligibility Criteria:
Inclusion Criteria
* Confirmed colorectal cancer with metastatic disease documented on diagnostic imaging studies.
* Measurable disease,
* Must have clinical documentation of failure after receiving at least one chemotherapy regimen for metastatic disease that contained irinotecan.
* Must have documentation of failure by CT, MRI or PET scan. Patients who were intolerant of irinotecan despite dose attenuations are not eligible for this trial.
* Patients must have failed irinotecan which they received on one of the following three starting regimens:Weekly,Biweekly or every 3 weeks. mg/m2.
6.Patients may have received any number of prior standard and investigational regimens or radiation treatments, provided that they meet all other eligibility criteria.
* Age greater than 18 years.
* Life expectancy of greater than 3 months.
* ECOG performance status less than 1
* Patients must have normal organ and marrow function
* Patients must have medical documentation of dose, schedule, and dates of last irinotecan administration.
* Women of child-bearing potential and men must agree to use adequate contraception
* Patients must have the ability to understand and the willingness to sign a written informed consent document.
Subject Exclusion Criteria
* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have recovered to \< grade 2.
* No other investigational agents.
* No known brain metastases.Patients with a history of primary CNS tumours, seizures not well controlled with standard medical therapy, or history of stroke will also be excluded.
* History of allergic reactions attributed to compounds of chemical or biologic composition similar to nimotuzumab, irinotecan, or other agents used in the study.
* Previous EGFR-directed therapy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled hypertension, clinically significant cardiac arrhythmia, history of myocardial infarction within the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
* HIV-positive patients on combination antiretroviral therapy are ineligible
* Active cardiovascular disease, e.g., uncontrolled hypertension, unstable angina, New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medications, or grade II or greater peripheral vascular disease. In addition, patients with arterial thrombosis, myocardial infarction, and cerebral vascular accidents \[stroke/transient ischemic attack (TIA)\] within 6 months prior to study entry will be excluded.
* Organ allografts requiring immunosuppressive therapy. -.Pregnant or lactating women are excluded from this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00493857
Study Brief:
Protocol Section:
NCT00493857