|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00016107 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: bevacizumab Drug: docetaxel Drug: estramustine phosphate sodium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer |
| Study Start Date: | June 2001 |
OBJECTIVES:
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| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Metastatic disease despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist
Measurable disease with any PSA level
Non-measurable disease with PSA at least 5 ng/mL
Progressive disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Veterans Affairs Medical Center - Birmingham | |
| Birmingham, Alabama, United States, 35233-1996 | |
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94143-0128 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| MBCCOP - University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612-7323 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Maine | |
| Veterans Affairs Medical Center - Togus | |
| Togus, Maine, United States, 04330 | |
| 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 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Missouri Baptist Cancer Center | |
| Saint Louis, Missouri, United States, 63131 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| Washington University Siteman Cancer Center | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New York | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| Syracuse, New York, United States, 13217 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| Schneider Children's Hospital at North Shore | |
| Manhasset, New York, United States, 11030 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| CCOP - Southeast Cancer Control Consortium | |
| Winston-Salem, North Carolina, United States, 27104-4241 | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Pennsylvania | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38103 | |
| Veterans Affairs Medical Center - Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| United States, Vermont | |
| Green Mountain Oncology Group | |
| Bennington, Vermont, United States, 05201 | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| Veterans Affairs Medical Center - White River Junction | |
| White River Junction, Vermont, United States, 05009 | |
| United States, Virginia | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Veterans Affairs Medical Center - Richmond | |
| Richmond, Virginia, United States, 23249 | |
| Canada, Quebec | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Study Chair: | Joel Picus, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
More Information
| Study ID Numbers: | CDR0000068595, CLB-90006 |
| Study First Received: | May 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00016107 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Growth Substances Physiological Effects of Drugs Estramustine Urogenital Neoplasms Bevacizumab Genital Diseases, Male |
Angiogenesis Inhibitors Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Alkylating Agents Prostatic Neoplasms |