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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Cancer and Leukemia Group B |
| 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer |
| Enrollment: | 79 |
| Study Start Date: | June 2001 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Chemotherapy + Antibody Therapy
Addition of antibody Bevacizumab to chemotherapy treatment
|
Biological: bevacizumab
15mg/kg IV infusion on Day 2 of each cycle
Drug: docetaxel
70mg/sq m IV infusion over 1 hour on Day 2 of each cycle
Drug: estramustine phosphate sodium
280 mg PO tid days 1- of each cycle
|
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
Show 55 Study Locations| Study Chair: | Joel Picus, MD | Washington University Siteman Cancer Center |
More Information
| Responsible Party: | Monica M Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00016107 History of Changes |
| Other Study ID Numbers: | CDR0000068595, U10CA031946, CLB-90006 |
| Study First Received: | May 6, 2001 |
| Last Updated: | March 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Estramustine Docetaxel Bevacizumab Sodium phosphate Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Cathartics Gastrointestinal Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |