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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT00227734
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic colorectal cancer
* Unresectable disease
* Primary tumor or metastases must be epidermal growth factor receptor-positive by immunohistochemistry
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by CT scan
* Measurable lesion must not be in a previously irradiated area
* No prior or current CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin normal
Renal
* Creatinine clearance \> 50 ml/min
Cardiovascular
* No New York Heart Association class III or IV congestive heart failure
* No symptomatic coronary artery disease
* No uncontrolled cardiac arrhythmia
* No myocardial infarction within the past 12 months
* No other significant cardiac disease
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 12 months after study participation
* Negative pregnancy test
* No peripheral neuropathy of any origin \> grade 1 (e.g., alcohol or diabetes)
* No nausea, vomiting, or malabsorption syndrome that would preclude ingestion or absorption of oral medication
* No severe reaction attributed to fluoropyrimidine therapy
* No known hypersensitivity to fluorouracil or any other component of the trial drugs
* No known dihydropyrimidine dehydrogenase deficiency
* No other medical condition (e.g., uncontrolled diabetes or active autoimmune disease), geographical situation, or psychiatric disorder that would preclude study compliance
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for advanced or metastatic cancer
* At least 6 months since prior adjuvant chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 30 days since prior experimental drugs
* No other concurrent experimental drugs
* No concurrent drugs that are contraindicated for use with the trial drugs
* No other concurrent anticancer therapy
* No concurrent sorivudine or any of its chemically-related analogues (e.g., lamivudine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00227734
Study Brief:
Protocol Section:
NCT00227734