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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT00132756
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed advanced, prostate cancer
* Patients must have evaluable disease that may be evaluated by PSA or measurement.
* Patients must be hormone refractory as defined in this protocol.
* Patients must be taxane refractory as defined in this protocol.
* Patients have had no prior chemotherapy other than a taxane or estramustine phosphate.
* Patients may have had prior radiation therapy (RT) if it has been \>/= 4 weeks since completion.
* Patients on bisphosphonates may be included.
* Patients must be at least 18 years of age or older.
* Patients must have the ability to speak and understand English.
* Patients must have an ECOG performance status of 2 or less.
* Patients must have adequate bone marrow function: platelets \> 100,000 cells/mm3; hemoglobin \> 9.0 g/dL; and absolute neutrophil count (ANC) \> 1,000 cells/mm3.
* Patients must have adequate renal function: creatinine \< 2.5 mg/dL.
* Patients must have adequate liver function.
* Ejection fraction of \> 50% within 42 days of first dose of study drug.
* Ability to complete the McGill-Melzack Pain Intensity Scale.
Exclusion Criteria:
* Patients with unstable medical conditions such as liver, renal dysfunctions, blood clots or heart disease.
* History of hypersensitivity to doxorubicin.
* History of class II cardiac disease or evidence of congestive heart failure.
* RT within the past 4 weeks of study entry or a radiopharmaceutical within the past 8 weeks of study entry.
* Prior malignancy within the past 5 years except for non-melanotic skin cancers.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00132756
Study Brief:
Protocol Section:
NCT00132756