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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00049335
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic or recurrent colorectal cancer not amenable to surgical resection
* Measurable disease
* No known brain metastases by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
* 70 and over OR
* 18 to 59
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase) no greater than 2 times ULN
Renal
* Creatinine no greater than 2 times ULN
* Creatinine clearance greater than 50 mL/min
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No known seizure disorder
* No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer currently in complete remission, or any other cancer for which the patient has been disease free for 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for advanced cancer
* Prior adjuvant chemotherapy allowed provided recurrence occurred more than 1 year after the last treatment
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 4 weeks since prior sorivudine or brivudine
* No concurrent sorivudine or brivudine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00049335
Study Brief:
Protocol Section:
NCT00049335