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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT00012220
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the pancreas
* Metastatic disease by CT scan
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* CTC 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN
* Alkaline phosphatase any value if SGOT less than 1.5 times ULN
Renal:
* Creatinine no greater than 1.5 mg/dL
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
* No other currently active malignancy (completed therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Chemotherapy:
* No prior chemotherapy except fluorouracil (5-FU)
* At least 2 weeks since prior 5-FU
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy for non-disease related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic
Radiotherapy:
* At least 2 weeks since prior radiotherapy
* No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00012220
Study Brief:
Protocol Section:
NCT00012220