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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT00968604
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic.
2. Patient must have received prior gemcitabine or a regimen containing oxaliplatin, irinotecan, and 5-FU with or without leucovorin for treatment of advanced or metastatic disease, unless the patient refused such treatment. Up to two prior chemotherapeutic regimens are permitted.
3. Patients must have measurable disease including liver metastases \>/= 2.0 cm amenable to percutaneous CT or U/S guided biopsy and must agree to undergo two liver biopsies.
4. Minimum of three weeks since any major surgery, radiation, or systemic anticancer therapy.
5. Any clinically significant residual adverse events from any prior anticancer therapy must have resolved to grade \</= 1 or baseline as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
6. Age \>/=18 years. Because no dosing or adverse event data are currently available on the use of gene therapy in patients \< 18 years of age, children are excluded from this study.
7. ECOG performance status 0 or 1.
8. Adequate hematologic, hepatic and renal parameters: leukocytes \>/= 3,000/microliter, absolute neutrophil count \>/= 1,500/microliter, platelets \>/= 100,000/microliter, hemoglobin \>/= 9g/dL, total bilirubin \</= 1.5 mg/dL, AST and ALT \</= 3 x upper limit of normal (ULN) for subjects with documented liver metastases; AST and ALT \</= 2.5 x ULN for subjects without evidence of liver metastases, creatinine \</= 1.5 mg/dL and calculated creatinine clearance of \>/= 60 mL/min.
9. PT/PTT are within normal limits.
10. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to treatment. Women must be surgically sterile or have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
11. Women of childbearing potential and men must agree to use double barrier contraception prior to study entry and continuing for 30 days after the last dose of study drug.
12. Signed written informed consent/authorization form.
Exclusion Criteria:
1. Prior treatment with any investigational drug within the preceding 3 weeks of Cycle 1, Day 1.
2. Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies are not required if the patient does not have a history of brain metastases and has no neurological signs or symptoms).
3. Other malignancies within the past 3 years of Cycle 1, Day 1 except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
4. Patients who have any known severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
5. A known history of HIV seropositivity.
6. Women who are pregnant or breast feeding.
7. History of MI within 6 months of Cycle 1, Day 1, angina, history of arrhythmias on active therapy, patients with LV ejection fraction \</= 50%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00968604
Study Brief:
Protocol Section:
NCT00968604