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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT00137761
Eligibility Criteria:
Inclusion Criteria:
* Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site.
* ECOG performance status of \< 1
* \> 4 weeks since completion of previous chemotherapy
* \> 4 weeks since participation in any investigational drug study
* Peripheral neuropathy of grade \< 1
* Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting.
* Absolute neutrophil count (ANC) \> 1,500/mm3
* Hemoglobin \> 9.0gm/dl
* Platelets \> 100,000/mm3
* Total bilirubin \< 2.0mg/dl
* AST and alkaline phosphatase \< 5 x upper limit of normal (ULN)
* Albumin \> 2.5gm/dl
* CA 19-9 \> 1.5 x ULN
Exclusion Criteria:
* Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors
* More than one prior chemotherapy treatment
* Clinically significant cardiac disease
* Major surgery within 4 weeks of the start of study treatment
* Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.
* Uncontrolled serious medical or psychiatric illness
* Pregnant or breast-feeding women
* Other active malignancy
* Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome
* Known severe hypersensitivity to Iressa
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort.
* History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
* Any evidence of clinically active interstitial lung disease
* Ascites requiring paracentesis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00137761
Study Brief:
Protocol Section:
NCT00137761