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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT00075595
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed colorectal adenocarcinoma
* Metastatic, unresectable disease
* Meets 1 of the following criteria:
* At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan
* Evaluable disease
* Evidence of disease (e.g., ascites or bone metastases) by imaging techniques
* Progressive disease as defined by 1 of the following criteria:
* Progressive disease while receiving first-line chemotherapy
* Recurrent disease within 6 months after completing adjuvant chemotherapy
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* WHO 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase \< 3 times ULN
Renal
* Not specified
Cardiovascular
* No uncontrolled angina
* No myocardial infarction within the past 6 months
Gastrointestinal
* No chronic diarrhea grade 2 or greater
* No unresolved fully or partially obstructed intestine
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other underlying disease or medical condition that would preclude study participation
* No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix
* No psychological, social, familial, or geographical condition that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* No prior irinotecan
Endocrine therapy
* Not specified
Radiotherapy
* At least 3 weeks since prior radiotherapy
Surgery
* At least 3 weeks since prior surgery
Other
* No other concurrent clinical trial participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00075595
Study Brief:
Protocol Section:
NCT00075595