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About
This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer
Full description
PRIMARY OBJECTIVES:
I. Determine the efficacy of ixabepilone (BMS-247550) vs mitoxantrone and prednisone, in terms of decline in prostate-specific antigen (PSA) levels, in patients with taxane-resistant, hormone-refractory metastatic prostate cancer.
SECONDARY OBJECTIVES:
I. Determine the safety of these regimens in these patients. II. Determine the objective response rate in patients with measurable disease who are treated with these regimens.
III. Determine the clinical activity of each of these regimens after crossover in patients who experience disease progression on their originally assigned treatment arm and switch to the other treatment arm.
OUTLINE: This is a randomized, crossover, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1 or 2). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive ixabepilone (BMS-247550) IV over 3 hours on day 1.
ARM II: Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21.In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients who progress while on treatment after at least 2 courses or discontinue treatment for any other reason may cross over to the other arm and receive treatment as above, beginning within 12 weeks of last study treatment on original arm.
Patients are followed every 3 months.
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Inclusion and exclusion criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate
Metastatic disease (positive bone scan or measurable disease)
Progressive hormone-refractory disease
Based on 1 of the following:
Must have undergone primary hormonal treatment (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without an antiandrogen) and demonstrated disease progression after antiandrogen discontinuation as defined below:
Ineligible if sole manifestation of progression is an increase in disease-related symptoms
Meets 1 of the following criteria:
Measurable disease and an elevated PSA
Nonmeasurable disease and an elevated PSA, as follows:
New metastatic lesions by radionuclide bone scan
Must have received at least 2 courses of paclitaxel- or docetaxel-based therapy, with disease progression documented during therapy or no more than 60 days after cessation of therapy*
Testosterone < 50 ng/dL
No known active brain metastases
Performance status - ECOG 0-2
At least 12 weeks
Granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin < 1.5 times upper limit of normal (ULN)
AST and ALT < 3 times ULN
Creatinine ≤ 1.5 times ULN
Creatinine clearance > 40 mL/min
Ejection fraction ≥ lower limit of normal by MUGA or echocardiogram
No myocardial infarction within the past 6 months
No significant cardiovascular disease
No New York Heart Association class III or IV congestive heart failure
No active angina pectoris
Fertile patients must use effective contraception before, during, and for 3 months after study therapy
No prior hypersensitivity reaction to agents containing Cremophor®EL
No serious infection
No nonmalignant medical illnesses that are uncontrolled or whose control would be jeopardized by complications of study therapy
No psychiatric illness or social situation that would preclude study compliance
No motor or sensory neuropathy grade 2 or greater
No "currently active" second malignancy except nonmelanoma skin cancer
No concurrent prophylactic colony-stimulating factors for myelosuppression
See Disease Characteristics
No more than 1 prior chemotherapy regimen
No prior mitoxantrone or epothilone
No other concurrent chemotherapy
See Disease Characteristics
At least 4 weeks since prior antiandrogens (e.g., flutamide) (6 weeks for bicalutamide or nilutamide)
At least 4 weeks since prior systemic (including oral) corticosteroids except corticosteroids as part of first-line chemotherapy tapered off over 10-14 days prior to study entry
At least 4 weeks since any prior hormonal therapy, including megestrol or finasteride
No other concurrent systemic steroids
At least 4 weeks since prior radiotherapy
More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
No concurrent radiotherapy
See Disease Characteristics
At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., Saw Palmetto or PC-SPES)
More than 4 weeks since other prior antiprostate cancer therapy
More than 4 weeks since prior systemic therapies for prostate cancer
No other concurrent investigational agents
Primary purpose
Allocation
Interventional model
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80 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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