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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT00028561
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
* Measurable or evaluable disease
* Lesion accessible for core or excisional biopsy if being treated at the maximum tolerated dose (MTD)
* No biliary tract dilation if radiologically guided biopsy of the liver is planned
* No requirement for core biopsy of lung lesion that is not pleural based
* No requirement for laparotomy or thoracotomy solely for biopsy
* No medical condition that would preclude biopsy
* No known brain metastases
* Performance status - ECOG 0-2
* Performance status - ECOG 0-1 if being treated at the MTD
* More than 3 months
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No prior bleeding disorder or unexplained bleeding if being treated at the MTD
* Bilirubin no greater than 1.5 mg/dL
* AST/ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
* PT/PTT normal
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 60 mL/min
* 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 other concurrent uncontrolled illness that would preclude study participation
* No ongoing or active infection
* No grade 2 or greater neuropathy (sensory or motor)
* No prior severe allergic reaction attributable to compounds containing Cremophor EL or platinum agents
* No psychiatric illness or social situation that would preclude study compliance
* No medical condition that would preclude study if being treated at the MTD
* At least 4 week since prior immunotherapy
* At least 24 hours since prior growth factors
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No more than 3 prior chemotherapy regimens
* No prior epothilone agents
* At least 1 week since prior hormonal therapy directed at malignancy
* Concurrent hormone replacement therapy allowed
* At least 4 weeks since prior wide-field radiotherapy involving 30% or more of bone marrow
* See Disease Characteristics
* At least 4 weeks since prior investigational agents
* No prior or concurrent St. John's Wort
* No concurrent combination anti-retroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No concurrent heparin or other anticoagulants if being treated at the MTD
* No concurrent inhibitors of cytochrome P450 3AP (CYP3A4)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00028561
Study Brief:
Protocol Section:
NCT00028561