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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005810
Enrollment
40
Registered
2004-04-19
Start date
2000-03-31
Completion date
2006-06-30
Last updated
2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALfilgrastim
DRUGcarboplatin
DRUGdocetaxel
DRUGestramustine phosphate sodium

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Response rateUp to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026