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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00110214 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than docetaxel and prednisone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with prostate cancer that did not respond to hormone therapy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: bevacizumab Drug: docetaxel Drug: placebo Drug: prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Docetaxel and Prednisone With and Without Bevacizumab (IND #7921, NSC #704865) In Men With Hormone Refratory Prostate Cancer |
Estimated Enrollment: | 1020 |
Study Start Date: | April 2005 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1. Patients also receive oral prednisone once daily on days 1-21.
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Drug: docetaxel
Docetaxel given IV; prednisone given orally
Drug: placebo
Given IV
Drug: prednisone
Docetaxel given IV; prednisone given orally
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Arm II: Experimental
Patients receive docetaxel and prednisone as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1.
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Drug: bevacizumab
Given IV
Drug: docetaxel
Docetaxel given IV; prednisone given orally
Drug: prednisone
Docetaxel given IV; prednisone given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to predicted 24-month survival probability (< 10% vs 10-29.9% vs ≥ 30%), age (< 65 years vs ≥ 65 years), and prior history of arterial events (i.e., cardiac ischemia/infarction, CNS cerebrovascular ischemia, peripheral arterial ischemia, or CNS hemorrhage) (yes vs no). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: Approximately 1,020 patients (510 per treatment arm) will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Meets 1 of the following criteria:
Measurable disease with any level of prostate-specific antigen (PSA)
Nonmeasurable disease AND PSA ≥ 5 ng/mL
The following are considered nonmeasurable disease:
Progressive systemic disease (since the most recent change in therapy) despite castrate levels of testosterone due to orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist therapy
Castrate levels of testosterone must be maintained
Progressive disease is defined as any of the following:
Measurable disease progression
Bone scan progression
PSA progression
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No arterial thrombotic events within the past 6 months, including any of the following:
Pulmonary
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
At least 4 weeks since any other prior hormonal therapy (e.g., ketoconazole, aminoglutethimide)
No concurrent hormonal therapy except for the following:
Radiotherapy
Surgery
Other
Concurrent bisphosphonates allowed provided patient is on a stable dose and initiated treatment ≥ 4 weeks prior to study entry
No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, or Hypericum perforatum [St. John's wort])
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, Colorado | |
Aurora Presbyterian Hospital | |
Aurora, Colorado, United States, 80012 | |
Boulder Community Hospital | |
Boulder, Colorado, United States, 80301-9019 | |
CCOP - Colorado Cancer Research Program | |
Denver, Colorado, United States, 80224-2522 | |
Hope Cancer Care Center at Longmont United Hospital | |
Longmont, Colorado, United States, 80502 | |
Sky Ridge Medical Center | |
Lone Tree, Colorado, United States, 80124 | |
Penrose Cancer Center at Penrose Hospital | |
Colorado Springs, Colorado, United States, 80933 | |
Porter Adventist Hospital | |
Denver, Colorado, United States, 80210 | |
Presbyterian - St. Luke's Medical Center | |
Denver, Colorado, United States, 80218 | |
Rose Medical Center | |
Denver, Colorado, United States, 80220 | |
North Suburban Medical Center | |
Thornton, Colorado, United States, 80229 | |
St. Joseph Hospital | |
Denver, Colorado, United States, 80218 | |
St. Mary - Corwin Regional Medical Center | |
Pueblo, Colorado, United States, 81004 | |
Swedish Medical Center | |
Englewood, Colorado, United States, 80110 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Georgia | |
MBCCOP - Medical College of Georgia Cancer Center | |
Augusta, Georgia, United States, 30912 | |
Veterans Affairs Medical Center - Augusta | |
Augusta, Georgia, United States, 30904 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1002 | |
McCreery Cancer Center at Ottumwa Regional | |
Ottumwa, Iowa, United States, 52501 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New Hampshire | |
Center for Cancer Care at Exeter Hospital | |
Exeter, New Hampshire, United States, 03833 | |
United States, New York | |
CCOP - Hematology-Oncology Associates of Central New York | |
East Syracuse, New York, United States, 13057 | |
Tucker Center for Cancer Care at Orange Regional Medical Center | |
Middletown, New York, United States, 10940-4199 |
Study Chair: | William K. Kelly, DO | Yale University |
Study Chair: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000427290, CALGB-90401, ECOG-90401 |
Study First Received: | May 4, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00110214 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Bevacizumab Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Growth Substances Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Glucocorticoids Hormones |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |