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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT00593060
Eligibility Criteria:
Inclusion Criteria:
* Previously treated metastatic colorectal adenocarcinoma, histologically proven. Subjects must have previously received and had evidence of progression on cetuximab, bevacizumab, 5FU, irinotecan, and oxaliplatin, or demonstrated intolerance to those agents (except cetuximab).
* Measurable disease by RECIST criteria
* ECOG Performance Status 0 or 1.
* Male or female, 18 years of age or older.
* Life expectancy greater than or equal to 12 weeks.
* At least 2 weeks have elapsed between previous anti-cancer therapy AND resolution of any skin rash related to prior treatment with an epidermal growth factor receptor inhibitor.
* Lab values within ranges as outlined in protocol
Exclusion Criteria:
* Diagnosis of second malignancy within the last 3 years, except for adequately treated basal cell carcinoma or squamous cell skin cancer.
* Ongoing cardiac dysrhythmias of NCI CTCAE grade \>/=2, atrial fibrillation, QTc prolongation to \>450msec for males and \>470 msec for females.
* Known immunodeficiency disorders or active infections requiring treatment
* Pregnancy or breastfeeding
* Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease
* Prior radiation therapy or major surgery within 2 weeks of study entry
* Prior radiation therapy to \> 25% of the bone marrow
* Treatment with other experimental or alternative therapies during the course of the trial
* History of hypersensitivity to polysorbate or cetuximab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00593060
Study Brief:
Protocol Section:
NCT00593060