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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT00274859
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed cancer
* Metastatic disease
* Measurable metastatic disease ≥ 1 cm by spiral CT scan and/or cutaneous lesion ≥ 2 cm
* Not a candidate for anthracycline or taxane chemotherapy
* No brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 12 weeks
* Neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Alkaline phosphatase \< 5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN
* Creatinine \< 1.5 times ULN OR creatinine clearance \> 30 mL/min
* SGOT and SGPT \< 3 times ULN (5 times ULN if liver metastases present)
* No pre-existing neuropathy
* Not pregnant or nursing
* No uncontrolled hypercalcemia
* No familial, social, geographical, or psychological condition that would preclude study treatment
* No other malignancy that is not considered cured
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for metastatic disease, including anthracyclines or taxanes
* Prior hormonal therapy allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00274859
Study Brief:
Protocol Section:
NCT00274859