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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT00126633
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Must have documented extrapancreatic metastases
* Radiographically measurable disease is not required
* Previously untreated disease
* No CNS or brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa \[Epogen®\] support allowed)
* No evidence of bleeding diathesis or coagulopathy
Hepatic
* INR ≤ 1.5 (except for patients receiving full-dose warfarin)
* Bilirubin ≤ 2.0 mg/dL
* AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
Renal
* Creatinine ≤ 2.0 mg/dL
* Urine protein:creatinine ratio ≤ 1
Cardiovascular
* No New York Heart Association class II-IV congestive heart failure
* No myocardial infarction or stroke within the past 6 months
* No uncontrolled hypertension (i.e., blood pressure \> 160/110 mm Hg despite antihypertensive therapy)
* No unstable angina
* No unstable symptomatic arrhythmia requiring medication
* Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
* No peripheral vascular disease ≥ grade 2
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No significant traumatic injury within the past 28 days
* No serious non-healing wound, ulcer, or bone fracture
* No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious systemic disease
* No history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* More than 28 days since prior major surgery, or open biopsy
* More than 7 days since prior fine needle aspirations or core biopsies
* No concurrent major surgery
Other
* No prior therapy, including systemic or investigational therapy, for locally advanced or metastatic pancreatic cancer
* Treatment given in the adjuvant setting (e.g., radiotherapy and/or chemotherapy, given either concurrently or systemically) is not considered prior therapy provided progressive disease occurred \> 6 months after completion of prior treatment
* Concurrent continuation of therapeutic doses of warfarin or low-molecular weight heparin allowed for pulmonary embolism, deep vein thrombosis, atrial fibrillation, or other clinical indications provided patients has been on a stable dose for ≥ 28 days with no further clotting or bleeding complications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00126633
Study Brief:
Protocol Section:
NCT00126633