A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or WITHOUT LENALIDOMIDE in Subjects With Castrate-Resistant Prostate Cancer
In November 2011, the Data Monitoring Committee concluded it was unlikely that the study
would meet its primary endpoint of overall survival (OS) and recommended that the study be
stopped. The study was terminated in accordance with this recommendation. All sites were
instructed to immediately discontinue all patients from experimental lenalidomide/placebo
treatment administered either in combination with chemotherapy or as a single agent
following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to
provide for the following:
To continue to collect information on Second Primary Malignancies (SPMs) and additional
treatments for Prostate Cancer in all randomized subjects during survival follow-up.
To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized
at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made
to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator
discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time
of Protocol Amendment 3 approval, an additional two cycles were provided.
All references to dosing and study procedures pertaining to the safety, efficacy, and
exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol
Amendment 3.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall Survival
Number of participants who survive
Cycle 1 Day 1 until subject death
No
Debora Barton, MD
Study Director
Celgene Corporation
United States: Food and Drug Administration
CC-5013-PC-002
NCT00988208
November 2009
November 2016
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
Texas Oncology, P.A. | Dallas, Texas 75246 |
Virginia Oncology Associates | Newport News, Virginia 23606 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Ocala Oncology Center | Ocala, Florida 34474 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
VA Puget Sound Health Care System | Seattle, Washington 98101 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Southwest Cancer Care | Poway, California 92064 |
South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
New York Oncology Hematology, P.C. | Albany, New York 12208 |
Oncology Hematology Care, Inc. | Cincinnati, Ohio 45219 |
Cancer Centers of Florida, P.A. | Orlando, Florida |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Central Indiana Cancer Centers | Indianapolis, Indiana 46227 |
Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
Allison Cancer Center | Midland, Texas 79701 |
Texoma Cancer Center | Wichita Falls, Texas 76310 |
Hematology Oncology Associates | Phoenix, Arizona 85012 |
Longview Cancer Center | Longview, Texas 75601 |
Comprehensive Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Columbia University Medical Center | New York, New York 10032 |
Maryland Oncology Hematology, P.A. | Columbia, Maryland 21044 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Cookeville Regional Medical Center | Cookeville, Tennessee 38501 |
Cancer Care & Hematology Specialists of Chicagoland | Niles, Illinois 60714 |
New Bern Cancer Care | New Bern, North Carolina 28560 |
Summit Medical Group | Summit, New Jersey 07901 |
Fairfax Northern VA Hem-Onc PC | Fairfax, Virginia 22031 |
Advocate Lutheran General Hospital | Park Ridge, Illinois 60068 |
Advanced Medical Specialties | Miami, Florida 33176 |
Weill Cornell Medical College | New York, New York 10021 |
Cancer Centers of North Carolina | Raleigh, North Carolina 27607 |
Florida Cancer Institute - New Hope | New Port Richey, Florida 34655 |
Va Long Beach Healthcare System | Long Beach, California 90822 |
Columbia Basin Hematology and Oncology | Kennewick, Washington 99336 |
City of Hope Cancer Center | Duarte, California 91010 |
Baylor Sammons Cancer Center | Dallas, Texas 75246 |
Southlake Oncology | Southlake, Texas 76092 |
Legacy Pharma Research | Bismarck, North Dakota 58501 |
VA Medical Center | White River Junction, Vermont 05009 |
Northwest Cancer Specialists-Tualatin | Tualatin, Oregon 97062 |
Hematology Oncology Associates of South Jersey | Mount Holly, New Jersey 08060 |
Arizona Oncology Associates D.B.A. Hematology Oncology Physicians & Extenders | Tucson, Arizona 85704 |
University of Southern California Medical Center | Los Angeles, California 90033 |
South Florida Hematology Oncology Group | Tamarac, Florida 33321 |
Hematology and Oncology Specialist, LLC | Metairie, Louisiana 70006 |
Hematology-Oncology Associates of NNJ P.A. | Morristown, New Jersey 07960 |
Ralph H. Johnson VA Medical Center | Charleston, South Carolina 29401 |
Texas Oncology North Austin | Austin, Texas 78759 |
Texas Oncology, P.S. - Paris | Paris, Texas 75460 |
Texas Oncology , P.A. - Tyler | Tyler, Texas 75702 |
Oncology and Hem Associates of SW VA, Inc. | Christiansburg, Virginia 24073 |