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 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT00112892
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor
* Metastatic or unresectable disease
* Standard curative or palliative treatments do not exist or are no longer effective OR treatment with single-agent irinotecan does not constitute a reasonable treatment option
* No known untreated or progressive brain metastases
* Previously treated brain metastases allowed provided all of the following are true:
* No significant neurological deficit
* No requirement for anti-epileptic medications
* Disease stable by brain CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 12 weeks
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin normal
* AST and ALT ≤ 3 times upper limit of normal
* Albumin ≥ 3.0 g/dL
* No Gilbert's disease
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No clinically significant cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to receive oral medications
* No active inflammatory bowel disease or chronic diarrhea
* No known HIV positivity
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)
Endocrine therapy
* Not specified
Radiotherapy
* At least 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent Hypericum perforatum (St. John's wort)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00112892
Study Brief:
Protocol Section:
NCT00112892