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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00885066
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Advanced disease
* No standard curative therapy available
* Must have received prior first-line chemotherapy
* No brain metastasis
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy ≥ 8 weeks
* ANC ≥ 1.5 x 10\^9/ L
* Platelet count ≥ 130 x 10\^9/ L
* Hemoglobin ≥ 10 g/dL
* Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
* Bilirubin ≤ 1.5 times ULN
* Creatinine ≤ 130 mmol/L OR creatinine clearance \> 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No intolerance or hypersensitivity to any of the drugs being tested
* No history of interstitial lung disease
* No history of severe cardiac disease
* No serious uncontrolled infection
* No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
* Must not be deprived of liberty or under guardianship
* Must not be on probation
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior erlotinib hydrochloride
* No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
* More than 14 days since participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00885066
Study Brief:
Protocol Section:
NCT00885066