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:
NCT00095966
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced or metastatic disease
* Locally advanced disease must extend outside the boundaries of a standard radiotherapy port
* Not amenable to curative surgery or radiotherapy
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Pleural effusion and ascites are not considered measurable lesions
* Outside prior radiotherapy port
* No known brain metastases
* Performance status - ECOG 0-1
* Performance status - Karnofsky 70-100%
* More than 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No evidence of bleeding diathesis
* Bilirubin normal
* AST and/or ALT ≤ 2.5 times upper limit of normal
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* No uncontrolled hypertension
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active or ongoing infection
* No other active malignancy
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No prior antiangiogenic agents
* No prior cytotoxic chemotherapy for metastatic disease
* At least 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No prior gemcitabine
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No prior investigational drugs
* No prior sorafenib
* No prior MAPK signaling agents
* Concurrent warfarin anticoagulation allowed provided the following criteria are met:
* Therapeutic on a stable warfarin dose
* INR ≤ 3
* Undergo weekly INR testing
* No active bleeding or pathological condition that carries a high risk of bleeding
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00095966
Study Brief:
Protocol Section:
NCT00095966