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

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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.

OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5. Patients receive
docetaxel IV over 1 hour followed by carboplatin IV over 1 hour on day 2. Filgrastim (G-CSF)
SC is administered beginning on day 6 and continuing until hematopoietic recovery. Treatment
continues every 21 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for a maximum of 2 years.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 10 months.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

William Oh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Federal Government

Study ID:




Start Date:

March 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Chicago Cancer Research Center Chicago, Illinois  60637
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
Dana-Farber Cancer Institute Boston, Massachusetts  02115