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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00551005
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven diagnosis of a malignant disease for which no satisfactory treatment exists at the time of enrollment
* Patients with brain metastases which at the time of study enrollment are controlled and do not require treatment with corticosteroids are eligible
PATIENT CHARACTERISTICS:
Inclusion criteria:
* WHO performance status 0-2
* Life expectancy ≥ 3 months
* ANC \> 1.5 x 10\^9/L
* Platelet count \> 100 x 10\^9/L
* Creatinine clearance \> 50 mL/min
* Serum bilirubin \< 1.5 mg/dL
* AST and ALT \< 2.0 times upper limit of normal (unless clearly due to the presence of tumor)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patient must be capable of understanding the nature of the trial and must give written informed consent
Exclusion criteria:
* Unstable or severe intercurrent medical conditions or active, uncontrolled infection
* History of allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs)
* History of bleeding peptic ulcer within the past 3 months
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
* Recovered from all prior chemotherapy or radiotherapy
* Concurrent aspirin for cardiovascular indications allowed
* More than 2 weeks since prior and no other concurrent NSAIDs
Exclusion criteria:
* Had radiotherapy or chemotherapy within 3 weeks (nitrosoureas or mitomycin C within 6 weeks) prior to anticipated first day of dosing
* Undergoing concurrent therapy with other investigational agents or antineoplastic therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00551005
Study Brief:
Protocol Section:
NCT00551005