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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00310050
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed carcinoma arising from the pancreas
* Stage II or III disease, meeting 1 of the following criteria:
* Nonresectable disease
* Potentially resectable disease
* Resectable disease
* Stage IV disease with symptomatic back pain requiring palliation allowed at the discretion of the principal investigator
* Measurable, evaluable, or nonmeasurable disease
* No neuroendocrine tumor of the pancreas
* No documented brain metastasis
* No clinically significant pleural or peritoneal effusions that cannot be drained
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
* AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
* Creatinine clearance ≥ 45 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No active infection
* No serious systemic disorders that would preclude study treatment
* No significant cardiovascular disease in the form of abnormal electrocardiogram coupled with clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina, or hypertension)
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior investigational agents
* No prior chemotherapy for pancreatic cancer
* Must be able to discontinue aspirin, dexamethasone, and other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after pemetrexed disodium dose (5 days before for long-acting agents such as piroxicam)
* Must be able and willing to take folic acid and cyanocobalamin (vitamin B12) supplementation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00310050
Study Brief:
Protocol Section:
NCT00310050