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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT00043095
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-hematological cancer that is unresponsive to currently available therapies or for which there is no known effective treatment
* Clinical or radiological evidence of disease required
* No active brain metastases, including evidence of cerebral edema (by CT scan or MRI), progression from prior imaging study, any requirement for steroids, or clinical symptoms
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin at least 8.0 g/dL
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* ALT and AST no greater than 2.5 times upper limit of normal (ULN) or 93 U/L
Renal
* Creatinine no greater than 1.5 times ULN or 2.0 mg/dL
Other
* No documented hypersensitivity reaction to prior paclitaxel or other therapy containing Cremophor EL
* No grade 2 or greater pre-existing peripheral neuropathy
* No serious uncontrolled medical disorder or active infection that would preclude study therapy
* No dementia or altered mental status that would preclude informed consent
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior immunotherapy
Chemotherapy
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)
* Prior taxanes allowed
* Prior adjuvant or neoadjuvant chemotherapy allowed
* No more than 2 prior chemotherapy regimens in the metastatic setting
* No other concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* No concurrent hormonal therapy except hormone-replacement therapy
* Concurrent medications to maintain castrate status for progressive hormone-refractory prostate cancer allowed
Radiotherapy
* At least 4 weeks since prior radiotherapy
* No prior radiotherapy to more than 25% of bone marrow
* No concurrent radiotherapy
Surgery
* Not specified
Other
* At least 4 weeks since prior investigational agents
* No other concurrent experimental anticancer medications
* No concurrent alternative therapies (e.g., high-dose vitamins or herbal medicines)
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00043095
Study Brief:
Protocol Section:
NCT00043095