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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT00559858
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of advanced colorectal or breast carcinoma
* Hormone receptor status not specified
* Receiving single-agent capecitabine chemotherapy
* Measurable disease for response assessment, determined on an individual patient basis, using conventional clinical and/or radiological methods
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Menopausal status not specified
* Life expectancy ≥ 12 weeks
* Hemoglobin ≥ 10 g/dL
* Platelet count ≥ 100,000 mm\^3
* WBC ≥ 3,000/mm\^3
* ANC ≥ 1,500/mm\^3
* Bilirubin ≤ 1.3 x upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 x ULN
* AST and ALT ≤ 5 x ULN
* Creatinine ≤ 1.5 x ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
* No medical or psychiatric condition which would influence the ability to provide informed consent
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 6 weeks since prior investigational agents
* Concurrent radiotherapy allowed
* No other concurrent chemotherapy or immunotherapy
* No concurrent nonsteroidal anti-inflammatory drugs NSAIDs) for the primary purpose of treating hand-foot syndrome (HFS) or cancer
* NSAIDs for conditions other than HFS or cancer allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00559858
Study Brief:
Protocol Section:
NCT00559858