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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00003851
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed unresectable primary or metastatic adenocarcinoma of the pancreas diagnosed within the past 8 weeks
* Stage II-IV
PATIENT CHARACTERISTICS:
Age:
* 18 to physiologic 65
Performance status:
* ECOG 0-2
Life expectancy:
* More than 2 months
Hematopoietic:
* WBC greater than 3,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 2.5 times normal
* SGOT or SGPT less than 1.5 times normal
* Albumin greater than 3.2 g/dL
Renal:
* Creatinine less than 1.5 times normal
* BUN less than 1.5 times normal
Other:
* Not pregnant or nursing
* HIV negative
* No other serious medical or psychiatric illness that would preclude study participation
* No serious infection
* Ability to eat solid food three meals per day
* No allergy or intolerance to pork
* No prior illicit drug addiction
* At least one year since prior daily alcohol use
* At least one year since prior cigarette use
* Must have supportive live-in spouse or other family member
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except:
* Steroids for antiemesis, documented CNS metastases, adrenal failure, or septic shock
* Hormonal therapy for nondisease related conditions (e.g., thyroid replacement therapy)
Radiotherapy:
* No prior radiotherapy
* Concurrent palliative radiotherapy allowed, including to a symptomatic lesion or one which may produce disability (e.g., unstable femur or CNS lesion)
Surgery:
* Greater than 1 week since prior exploratory or palliative bypass surgery
* No prior Whipple procedure or surgical procedure for curative intent
Other:
* No oral hypoglycemic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00003851
Study Brief:
Protocol Section:
NCT00003851