Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
- 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
- Patients may have had prior radiation therapy (RT) if it has been >/= 4 weeks since
- 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.
- 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.