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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT00126620
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor
* Metastatic or unresectable disease
* Standard curative or palliative measures do not exist OR are no longer effective
* Measurable disease by radiography (for patients treated at the maximum tolerated dose \[MTD\] only)
* Tumor accessible for serial biopsies (for patients treated at the MTD only)
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* More than 12 weeks
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No bleeding diathesis or coagulopathy
Hepatic
* Bilirubin normal
* AST and ALT ≤ 2.5 times ULN
* PT INR ≤ 1.5 unless on full-dose warfarin
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 140 mm Hg or diastolic BP \> 90 mm Hg despite medication)
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Ophthalmic
* No abnormalities of the cornea, including any of the following:
* Dry eye syndrome
* Sjögren's syndrome
* Congenital abnormalities (e.g., Fuch's dystrophy)
* Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
* Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
Gastrointestinal
* No active peptic ulcer disease that would impair the ability to swallow pills
* No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to undergo serial biopsies, positron emission tomography, and CT scanning (for patients treated at the MTD only)
* No ongoing or active infection
* No significant traumatic injury within the past 3 weeks
* No history of allergic reaction to drugs of similar chemical or biological composition to study drugs
* No psychiatric illness or social situation that would preclude study compliance
* No other condition that would impair the ability to swallow pills
* No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic hematopoietic colony-stimulating factors
Chemotherapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy (except for low dose, non-myelosuppressive radiotherapy) and recovered
Surgery
* More than 3 weeks since prior major surgery
* No prior surgical procedure affecting absorption
Other
* No prior sorafenib or erlotinib
* No other prior agents targeting Raf, vascular endothelial growth factor (VEGF), VEGF receptor, or epidermal growth factor receptor
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
* No concurrent CYP3A4 inducers (e.g., rifampin or Hypericum perforatum \[St. John's wort\])
* No other concurrent anticancer therapy
* Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided PT INR \< 1.1 times upper limit of normal (ULN)
* Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided both of the following criteria are met:
* Patient has an in range INR (between 2-3) while on a stable-dose of oral anti-coagulant OR a stable-dose of low molecular weight heparin
* No active bleeding OR pathological condition that would confer a high risk of bleeding (e.g., tumor involving a major vessel or known varices)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00126620
Study Brief:
Protocol Section:
NCT00126620