Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2000
End Date:June 2006

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A Phase II Study of Estramustine, Docetaxel, and Carboplatin With G-CSF Support in Men With Hormone Refractory Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the
number of immune cells found in bone marrow or peripheral blood and may help a person's
immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus
filgrastim in treating patients who have stage IV prostate cancer that has not responded to
hormone therapy.

OBJECTIVES: I. Determine the response rate (objective and PSA response) and duration of
response to estramustine, docetaxel, and carboplatin with filgrastim (G-CSF) support in
patients with hormone refractory prostate cancer. II. Determine the toxicity of this regimen
in this patient population.

DISEASE CHARACTERISTICS: Histologically confirmed stage IV adenocarcinoma of the prostate
Failure on standard hormone therapy Measurable disease with any PSA Accurately measured in
at least 1 dimension as at least 20 mm by physical exam for clinically palpable lymph
nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions
surrounded by aerated lung OR those lesions measured as at least 10 mm by spiral CT scan
OR Nonmeasurable disease with PSA at least 5 ng/mL Nontarget lesions including small
lesions with longest diameter less than 20 mm by conventional techniques or less than 10
mm by spiral CT scan and truly nonmeasurable lesions including: Bone lesions Pleural or
pericardial effusions Ascites CNS lesions Leptomeningeal disease Irradiated lesions unless
progression documented after radiotherapy Documented progressive systemic disease despite
at least 1 endocrine manipulation with either orchiectomy or LHRH agonist (which must be
continued), or diethylstilbestrol For measurable disease: Objective evidence of increase
of greater than 20% in the sum of the longest diameters of target lesions from the time of
maximal regression or the appearance of 1 or more new lesions For nonmeasurable disease:
If bone only disease, appearance of 1 new lesion on bone scan attributable to prostate
cancer along with a PSA of at least 5 ng/mL OR An elevated PSA (at least 5 ng/mL) that has
risen serially from baseline on 2 occasions each at least 1 week apart Testosterone no
greater than 50 ng/mL if no prior bilateral orchiectomy

PATIENT CHARACTERISTICS: Age: 18 to 99 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.0 times upper limit of normal (ULN) AST no greater
than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No
myocardial infarction or significant change in anginal pattern within past 1 year No
congestive heart failure No New York Heart Association class II-IV heart disease No deep
venous thrombosis or pulmonary embolus within past 1 year Other: Fertile patients must use
effective contraception No clinically significant peripheral neuropathy No known
hypersensitivity to E. coli derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF)
Chemotherapy: No prior chemotherapy No prior estramustine or suramin No other concurrent
chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior
antiandrogens Primary testicular androgen suppression (e.g., with an LHRH analogue) should
not be discontinued Concurrent LHRH analogue allowed if no prior bilateral orchiectomy
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiation and
recovered At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153
lexidronam pentasodium No concurrent palliative radiotherapy Surgery: See Disease
Characteristics At least 4 weeks since prior major surgery and recovered
We found this trial at
7
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chapel Hill, North Carolina 27599
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Lebanon, New Hampshire 03756
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San Francisco, California 94143
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