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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT00169000
Eligibility Criteria:
Inclusion Criteria:
* Patients with a histologically or cytologically proven metastatic solid tumor.
* Patients with measurable disease or an evaluable bone lesion that will not undergo biopsy.
* Patients treated within the additional cohort at MTD will have metastatic breast cancer with a site of disease that is amenable to percutaneous FNA and must be willing to undergo serial FNA biopsies of their primary tumor.
* Age \> 18 years.
* Life expectancy of at least 6 months.
* ECOG performance status 0-2.
* Adequate hematologic, hepatic, and renal function
* Patients must have an intact upper gastrointestinal tract, be able to swallow tablets, and not have a malabsorption syndrome.
Exclusion Criteria:
* No significant uncontrolled infectious or cardiovascular disease, or a myocardial infarction within the prior 12 months.
* No prior organ allograft.
* No prior treatment with capecitabine or with docetaxel.
* No prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
* No concurrent antacid therapy is allowed.
* No other significant medical/surgical diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00169000
Study Brief:
Protocol Section:
NCT00169000