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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT00496704
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced colorectal adenocarcinoma
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
* Must have received prior irinotecan hydrochloride with a progression-free interval of \< 3 months
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
* Creatinine ≤ 1.5 times ULN
* No significant cardiac abnormalities by ECG
* No known hypersensitivity to the study drugs or any of their components
* No myocardial infarction within the past 12 months
* No uncontrolled congestive heart failure
* No cardiovascular disorder ≥ grade 3 despite treatment
* No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
* No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy)
* No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
* No legal incapacity or limited legal capacity that would preclude study participation
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from all prior therapy
* More than 30 days since prior participation in another clinical trial
* No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00496704
Study Brief:
Protocol Section:
NCT00496704