Ixabepilone With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the prostate Must have disease progression meeting 1 of the following criteria: Rising prostate-specific antigen (PSA) on at least 3 consecutive measurements taken more than 1 week apart Measurable disease, defined as new or progressive soft tissue masses on CT scan or MRI New metastatic lesions by radionuclide bone scan The most recent PSA must be at least 4 ng/mL if no measurable disease is present Ineligible if sole manifestation of progressive disease is an increase in disease-related symptoms Serum testosterone no greater than 50 ng/mL One of the following therapies for maintenance of castrate status required: Must continue on gonadotropin-releasing hormone analogs (e.g., leuprolide or goserelin) to maintain castrate levels of serum testosterone Developed disease progression after discontinuation of the antiandrogen that was part of the first-line hormonal therapy Prior surgical orchiectomy Developed disease progression after discontinuation of megestrol No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of bleeding disorder that would preclude anticoagulation with warfarin Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal (ULN) PT/PTT normal (unless anticoagulated for other reasons [e.g., atrial fibrillation]) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No significant cardiovascular disease No symptomatic congestive heart failure No New York Heart Association class III or IV heart disease No active unstable angina pectoris No cardiac arrhythmia No myocardial infarction within the past 6 months No history of hemorrhagic or thrombotic cerebrovascular accident or deep venous thrombosis within the past 6 months Pulmonary: No pulmonary embolism within the past 6 months Other: Fertile patients must use effective contraception No history of allergic reactions to compounds of similar chemical or biological composition to the epothilones No history of recent gastrointestinal bleeding that would preclude anticoagulation with warfarin No other concurrent active malignancy except nonmelanomatous skin cancer Disease not considered currently active if completely treated with less than a 30% risk for relapse No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) except for neutropenic fever No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: No prior palliative radiotherapy to more than 25% of bone marrow No prior radioisotope therapy with strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium No concurrent therapeutic radiotherapy Concurrent focal radiotherapy for palliation of bone disease-related symptoms allowed at the investigator's discretion Surgery: See Disease Characteristics At least 4 weeks since prior major surgery Other: No other concurrent anticancer investigational or commercial agents or therapies No concurrent herbal, alternative, or food supplements (e.g., PC-SPES, saw palmetto, or St. John's Wort) No concurrent combination antiretroviral therapy for HIV-positive patients No initiation of bisphosphonates immediately before or during study Concurrent bisphosphonates allowed if developed disease progression while on stable doses Concurrent daily multivitamin allowed
Sites / Locations
- UCSF Comprehensive Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- University of Michigan Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center