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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT00997958
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of pancreas.
* Disease stage IV, locally advanced and/or metastatic.
* Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scan.
* The following lesions conventionally are not considered measurable:
* CNS lesions
* Blastic or lytic bone lesions (which will be documented and followed)
* Radiated lesions unless progression after RT is documented
* Ineligible for other high priority national or institutional studies.
* Prior therapy allowed:
* Chemotherapy (at least one prior regimen)
* \> 3 weeks since last chemotherapy
* \> 3 weeks since surgery
* ≥ 4 weeks since RT
* Non pregnant, non lactating women with a negative serum α-HCG test within one week of starting the study, AND
* Must be willing to consent to the use of two forms of contraception (at least one barrier) if of childbearing potential while on trial and six weeks after CellCept has been stopped.
* Clinical Parameters:
* Life expectancy ≥ 3 months
* Age 18 to 70 years
* Brain CT or MRI no visible metastases
* Performance status 0-2 (ECOG- see appendix B)
* HIV negative or never tested
* Required initial laboratory data:
* Normal
* White cell count ≥3000 cells / μl
* Platelet count ≥100,000 platelets / μl
* BUN ≤1.5 x normal 20 mg/dl
* Creatinine ≤1.5 x normal 1.0 mg/dl
* Total Bilirubin ≤3.0 mg/dl
* AST, ALT ≤3.0 x normal 38 U/L
* Alkaline Phosphatase ≤3.0 x normal 96 U/L
* Albumin ≥2.5 g/dl
* Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, adverse effects, risks, and discomforts.
* Prior malignancy in last 5 years: The cancer must be curatively treated carcinoma in situ of the cervix or skin cancer.
* No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
* Absence of concurrent treatment with cholestyramine, acyclovir, cyclosporine, or antacids with magnesium or aluminum hydroxides because of their effects on drug metabolism and serum levels of MPA.
* Absence of active serious digestive system disease as defined at the discretion of the Principal Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00997958
Study Brief:
Protocol Section:
NCT00997958