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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00064051
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed pancreatic cancer
* Unresectable or metastatic disease
* Measurable disease
* Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy
* No CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* More than 3 months
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL (transfusion allowed)
Hepatic
* Bilirubin no greater than 2.0 mg/dL
* AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)
* Chronic viral hepatitis allowed
Renal
* Creatinine no greater than 2.0 mg/dL
Cardiovascular
* No myocardial infarction within the past 3 months
* No uncontrolled congestive heart failure
* No uncontrolled coronary artery disease
* No uncontrolled arrhythmias
Pulmonary
* No dyspnea at rest
* No dependence on supplemental oxygen
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No other malignancy except any of the following:
* Carcinoma in situ of the cervix treated with cone biopsy or resection
* Nonmetastatic basal cell or squamous cell skin cancer
* Any stage I malignancy curatively resected more than 5 years ago
* No active infection
* No known or suspected glucose-6-phosphate dehydrogenase deficiency
* No other concurrent life threatening illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed
Chemotherapy
* No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery
* More than 3 weeks since prior surgery and recovered
Other
* More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00064051
Study Brief:
Protocol Section:
NCT00064051