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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT00030732
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma
* No CNS metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Karnofsky 60-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL
Hepatic:
* Bilirubin no greater than 5 times normal
* AST/ALT no greater than 5 times normal
* Alkaline phosphatase no greater than 5 times normal
Renal:
* Creatinine clearance at least 30 mL/min
Gastrointestinal:
* No grade 2 or greater nausea or grade 1 or greater vomiting
* No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction)
Other:
* No prior unanticipated severe reaction to fluoropyrimidine therapy
* No known hypersensitivity to fluorouracil
* No known dihydropyrimidine dehydrogenase deficiency
* No active infection
* No other serious concurrent systemic disorders that would preclude study participation
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior capecitabine
* No prior chemotherapy for advanced pancreatic cancer
* At least 1 year since prior radiochemotherapy for pancreatic cancer
Endocrine therapy:
* Not specified
Radiotherapy:
* See Chemotherapy
* At least 1 year since prior adjuvant radiotherapy for pancreatic cancer
* No concurrent radiotherapy
Surgery:
* Prior Whipple procedure or duodenal bypass allowed
Other:
* At least 1 month since prior investigational agents
* No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
* No other concurrent anticancer or investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00030732
Study Brief:
Protocol Section:
NCT00030732