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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00084734
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor for which standard curative or palliative measures do not exist or are no longer effective
* Metastatic or unresectable disease
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* More than 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
Hepatic
* AST and ALT ≤ 2.0 times upper limit of normal (ULN) AND alkaline phosphatase \[AP\] \< ULN OR
* AP ≤ 4 times ULN AND AST and ALT \< ULN
* Bilirubin normal
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to ingest oral medications
* No allergy attributed to study drugs, compounds of similar chemical or biological composition, drugs formulated in polysorbate 80, or other agents used in this study
* No inner ear auditory toxicity ≥ grade 2
* No peripheral neuropathy ≥ grade 2
* No immunodeficiency
* No active or ongoing infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent growth factors (sargramostim \[GM-CSF\] or filgrastim \[G-CSF\])
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 and recovered
Surgery
* Not specified
Other
* No other concurrent investigational agents unless approved by the principal investigator and medical monitor
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00084734
Study Brief:
Protocol Section:
NCT00084734