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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT00111904
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed epithelial carcinoma of the pancreas
* Unresectable\* locally advanced or metastatic disease NOTE: \*Documented by high-quality contrast-enhanced CT scan
* No known or clinical evidence of CNS metastasis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
* No unstable or serious medical condition
* No psychiatric disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for pancreatic cancer
* Prior fluorouracil as a radiosensitizer allowed
Endocrine therapy
* Not specified
Radiotherapy
* More than 6 weeks since prior radiotherapy for pancreatic cancer
* Disease must have progressed after completion of radiotherapy
Surgery
* More than 14 days since prior major surgery and recovered
Other
* More than 30 days since prior investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00111904
Study Brief:
Protocol Section:
NCT00111904