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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT00303927
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed pancreatic cancer
* Stage IV disease
* Measurable disease (≥ 1 cm or \> 10 mm lesion(s) by spiral CT scan)
* Disease progression after ≥ 1 gemcitabine-based treatment regimen for advanced/metastatic disease
* Patient carries the double tandem repeat (S/S) variant of the thymidylate synthase gene enhancer region (TSER)
* No active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if attributable to liver metastases)
* Total bilirubin ≤ 1.5 times ULN
* Creatinine normal OR creatinine clearance \> 50 mL/min
* Fertile patients must use effective contraception during and for 30 days after completion of study treatment
* Not pregnant or nursing
* Negative pregnancy test
* Asymptomatic HIV infection allowed
* No recent or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, bleeding, inflammation, emesis, or diarrhea \> grade 1)
* Able to swallow capecitabine tablets
* No known hypersensitivity to fluorouracil
* No dihydropyrimidine dehydrogenase (DPD) deficiency
* No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication)
* No myocardial infarction within the past 6 months
* No serious, uncontrolled, concurrent infection(s)
* No prior unanticipated severe reaction to fluoropyrimidine therapy
* No other malignancy within the past 5 years except cured nonmelanoma skin cancer or treated carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy
* No prior capecitabine except in the adjuvant setting
* At least 3 weeks since prior radiotherapy or major surgery
* At least 4 weeks since prior participation in any investigational drug study
* At least 4 weeks since prior sorivudine or brivudine
* No concurrent sorivudine or brivudine
* No concurrent cimetidine or azidothymidine (AZT)
* Concurrent radiotherapy for bone pain allowed to a limited field provided ≥ 1 indicator lesion remains outside of the field
* No other concurrent chemotherapy or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00303927
Study Brief:
Protocol Section:
NCT00303927