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 |
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.
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.
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
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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