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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00073905
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed biliary tract cancer
* Locally advanced, unresectable, or metastatic disease
* Metastatic adenocarcinoma with clinical documentation of gallbladder or bile tree involvement with no evidence of another primary adenocarcinoma allowed
* Measurable or nonmeasurable disease
* Treatable biliary duct obstruction must be relieved by either internal endoscopic drainage/stenting or palliative bypass surgery before study entry
* Symptomatic biliary tract cancer and has at least 1 of the following:
* Karnofsky 60-80%
* Baseline analgesic consumption at least 10 mg of morphine equivalents per day
* Baseline pain intensity score of at least 20 mm out of a possible 100 mm
* No prior or concurrent CNS metastasis
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* See Disease Characteristics
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL
Hepatic
* Bilirubin no greater than 4 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 5 times ULN
* AST and ALT no greater than 5 times ULN
Renal
* Creatinine clearance greater than 50 mL/min
Cardiovascular
* No uncontrolled cardiovascular disease
Gastrointestinal
* Able to ingest oral medication
* No malabsorption syndrome
* No intractable nausea and/or vomiting
* No partial small bowel obstruction
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 year after study participation
* No active autoimmune disease
* No uncontrolled diabetes
* No known hypersensitivity to fluorouracil
* No known dihydropyrimidine dehydrogenase deficiency
* No definitive contraindication to corticosteroids
* No prior significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) that would preclude understanding or providing informed consent
* No prior severe reaction to fluoropyrimidine therapy
* No psychiatric disorder, cognitive dysfunction, or language problem that would preclude filling out the quality of life questionnaire or patient diary
* No other serious underlying medical condition that would preclude study participation
* No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy
* No prior immunotherapy
Chemotherapy
* No prior chemotherapy for advanced/metastatic disease
* No prior palliative chemotherapy
Endocrine therapy
* No concurrent megestrol
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
* Treatment of a single painful lesion allowed
Surgery
* See Disease Characteristics
* Prior Whipple procedure allowed
* Prior duodenal bypass allowed
* No concurrent endoscopic or external biliary drainage as a consequence of progressive malignant bile duct obstruction
* Drainage as a consequence of nonmalignant bile duct obstruction allowed
Other
* More than 30 days since prior treatment within a clinical study
* No other concurrent anticancer drugs
* No other concurrent investigational drugs
* No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00073905
Study Brief:
Protocol Section:
NCT00073905