Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer

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.