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Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Human subjects often obtain the finest healthcare possible for their Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy  Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: adenocarcinoma of the prostate,stage 4 prostate cancer,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamOh, Study Chair, Cancer and Leukemia Group B
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Additional Information:
Study ID Numbers: CDR0000067811; CLB-99813
Study Start Date: March 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005810
Other Adenocarcinoma Of The Prostate Studies:
1. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
2. Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer
3. BMS-247550 With or Without Estramustine in Treating Patients With Progressive Prostate Cancer
4. Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
5. CT Scans in Guiding the Treatment of Patients With Prostate Cancer Who are Undergoing Radiation Therapy
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
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