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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT00030368
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which there is no curative treatment
* No known brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal (ULN)
* Creatinine no greater than ULN
* Left ventricular function at least lower limit of normal if received prior doxorubicin
* No grade II or IV tilt-table test
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No thrombotic event within the past 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction to compounds of similar chemical or biological composition to study drugs
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* Prior paclitaxel allowed
* At least 2 weeks since prior hormonal therapy
* No concurrent steroids or hormonal therapy except steroids to prevent hypersensitivity reactions to paclitaxel or hormonal therapy for non-disease-related conditions (e.g., insulin for diabetes)
* At least 4 weeks since prior radiotherapy
* At least 4 weeks since prior surgery
* Recovered from prior therapy
* No other concurrent investigational agents
* No concurrent combination anti-retroviral therapy for HIV-positive patients
* No concurrent anticoagulation therapy
* Concurrent pamidronate or zoledronate allowed for treatment of hypercalcemia or for palliation of skeletal metastases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00030368
Study Brief:
Protocol Section:
NCT00030368