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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer  Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
For Condition: recurrent prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate
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. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy.
Details: OBJECTIVES: I. Determine the time to objective progression, response rate, and duration of response in patients with hormone-refractory metastatic prostate cancer treated with bevacizumab, estramustine, and docetaxel. II. Determine the toxicity of this regimen in these patients. III. Assess the relationship of baseline vascular endothelial growth factor levels in urine and plasma and changes in these levels with response and duration of response in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to urine vascular endothelial growth factor level (low vs high). Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour followed by bevacizumab IV over 30-90 minutes on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 2 years. PROJECTED ACCRUAL: A total of 72 patients (36 per stratum) will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed adenocarcinoma of the prostate Metastatic disease after at least 1 prior endocrine manipulation with orchiectomy, LHRH agonist, or diethylstilbestrol - Refractory to standard hormonal therapy Measurable disease with any PSA level - Target lesion at least 20 mm by physical exam or chest x-ray OR - At least 10 mm by spiral CT scan - Histological confirmation of neoplastic nature required if disease is confined to only 1 target lesion OR Non-measurable disease with PSA at least 5 ng/mL - Bone lesions - Pleural or pericardial effusions or ascites - CNS lesions or leptomeningeal disease - Previously irradiated lesions, unless progression documented after radiotherapy Progressive disease - Objective evidence of greater than 20% increase in the sum of the longest diameters of target lesions for measurable disease - Progression by bone scan or PSA for non-measurable disease Castrate levels of testosterone must be maintained Serum testosterone no greater than 50 ng/mL for patients without prior bilateral orchiectomy --Prior/Concurrent Therapy-- Biologic therapy: No prior antiangiogenesis agents, including thalidomide and bevacizumab Chemotherapy: - No prior cytotoxic chemotherapy, including estramustine and suramin - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior antiandrogen therapy except testicular androgen suppression (e.g., LHRH analog) - No concurrent hormonal therapy except steroids for adrenal insufficiency or nondisease-related conditions (e.g., insulin for diabetes) - Concurrent testicular androgen suppression required, if initiated before study Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery and recovered Other: - No requirement for full-dose or parenteral anticoagulation - Daily prophylactic aspirin allowed --Patient Characteristics-- Age: Any age Performance status: CTC (ECOG) 0-2 Life expectancy: Not specified Hematopoietic: - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST no greater than 1.5 times ULN Renal: - Creatinine no greater than 1.5 times ULN - Urinalysis no greater than 1+ protein on dipstick Cardiovascular: - No myocardial infarction or significant change in anginal pattern within the past year - No congestive heart failure (New York Heart Association class II-IV heart disease) - No deep vein thrombosis within the past year Pulmonary: No pulmonary embolus within the past year Other: - No clinically significant peripheral neuropathy - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoelPicus, Study Chair, Cancer and Leukemia Group B
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Washington University Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612-7323
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Additional Information:
Study ID Numbers: CDR0000068595; CLB-90006
Study Start Date: June 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016107
Other Adenocarcinoma Of The Prostate Studies:
1. Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
2. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer
3. Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
4. Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
5. Hydrocortisone Plus Aminoglutethimide or Ketoconazole in Treating Patients With Localized Stage IV Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
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