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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00470535
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced inoperable or metastatic disease (stage III or IV disease)
* No more than 1 prior systemic therapy
* Patients who have not received 1 prior systemic therapy must meet 1 of the following criteria:
* Ineligible for or refused chemoradiotherapy AND has stage III disease
* Ineligible for or refused gemcitabine hydrochloride-based chemotherapy AND has stage IV disease
* No brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* WBC \> 3,000/mm³
* ANC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Bilirubin ≤ 2 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with documented liver metastases)
* Creatinine \< 1.5 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study therapy
* No uncontrolled comorbid illness that is likely to increase toxicity of the study drug or to interfere with toxicity evaluation
* No known allergy to the study drug or its excipients
* No symptomatic interstitial pulmonary disease
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior adjuvant therapy allowed provided it was completed at least 28 days prior to study entry
* No prior EGFR-inhibitor
* No concurrent drugs that are known to be strong inducers or inhibitors of the CYP450 enzyme system
* No concurrent Hypericum perforatum (St. John's wort)
* No concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00470535
Study Brief:
Protocol Section:
NCT00470535