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 @ 1:10 PM
Ignite Modification Date:
2025-12-24 @ 1:10 PM
NCT ID:
NCT00042861
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor that is metastatic or unresectable and for which no standard curative or palliative measures exist or are effective
* No brain metastases or primary CNS malignancy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 3 times upper limit of normal
Renal
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No known active coronary artery disease
Pulmonary
* No pulmonary dysfunction
Other
* HIV negative
* No history of unusually severe and/or prolonged toxicity during prior therapy with fluorouracil (5-FU) or 5-FU prodrugs
* No diabetes mellitus requiring insulin or oral hypoglycemic therapy
* No ongoing or active infection requiring IV antibiotics
* No other serious concurrent medical illness that would preclude study
* No psychiatric illness or social situations that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent cytokines during the first course of therapy
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
* No concurrent systemic corticosteroids
Radiotherapy
* At least 2 weeks since prior radiotherapy and recovered
* No prior pulmonary or mediastinal radiation exceeding 40 Gy
Surgery
* Recovered from prior surgery
Other
* No other concurrent investigational agents
* No concurrent cimetidine
* No concurrent sorivudine or brivudine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00042861
Study Brief:
Protocol Section:
NCT00042861