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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005810 |
Purpose
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.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: carboplatin Drug: docetaxel Drug: estramustine phosphate sodium Drug: filgrastim |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Carboplatin Filgrastim Docetaxel Granulocyte colony-stimulating factor Estramustine Estramustine phosphate Estramustine phosphate sodium |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Estramustine, Docetaxel, and Carboplatin With G-CSF Support in Men With Hormone Refractory Prostate Cancer |
| Study Start Date: | March 2000 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |||||
| UCSF Cancer Center and Cancer Research Institute | |||||
| San Francisco, California, United States, 94115-0128 | |||||
| United States, Illinois | |||||
| University of Chicago Cancer Research Center | |||||
| Chicago, Illinois, United States, 60637 | |||||
| United States, Maryland | |||||
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| United States, Massachusetts | |||||
| Dana-Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| United States, New Hampshire | |||||
| Norris Cotton Cancer Center | |||||
| Lebanon, New Hampshire, United States, 03756 | |||||
| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| United States, North Carolina | |||||
| Lineberger Comprehensive Cancer Center, UNC | |||||
| Chapel Hill, North Carolina, United States, 27599-7295 | |||||
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | William Oh, MD | Dana-Farber Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Oh WK, Halabi S, Kelly WK, Werner C, Godley PA, Vogelzang NJ, Small EJ; Cancer and Leukemia Group B 99813. A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813. Cancer. 2003 Dec 15;98(12):2592-8.
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Oh WK, Halabi S, Kelly WK, et al.: A phase II study of estramustine, docetaxel, and carboplatin (EDC) with G-CSF support in men with hormone refractory prostate cancer (HRPC): CALGB 99813. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-779, 2002.
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| Study ID Numbers: | CDR0000067811, CLB-99813 |
| First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005810 |
| Health Authority: | United States: Federal Government |
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