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Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: May 6, 2001   Last Updated: February 6, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2001
Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the toxicity of this regimen in these patients.
  • 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.

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
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist

    • Refractory to standard androgen deprivation 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

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • CTC (ECOG) 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

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

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 any hormonal therapy, including ketoconazole, aminoglutethimide, corticosteroids, flutamide, or megestrol
  • At least 6 weeks since prior bicalutimide and nilutimide
  • No concurrent hormonal therapy except steroids for adrenal insufficiency or nondisease-related conditions (e.g., insulin for diabetes)
  • Concurrent testicular androgen suppression (e.g., LHRH analog) allowed, 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
  • No concurrent bisphosphonate therapy unless initiated at least 1 month prior to study with progressive disease despite this therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016107

  Hide Study Locations
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
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Joel Picus, MD Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  More Information

Additional Information:
Publications:
Picus J, Halabi S, Rini B, et al.: The use of bevacizumab (B) with docetaxel (D) and estramustine (E) in hormone refractory prostate cancer (HRPC): initial results of CALGB 90006. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1578, 2003.

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

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009