A Multicenter Phase II Evaluation of Targretin (Bexarotene) Capsules in Patients With Advanced Breast Cancer
OBJECTIVES: I. Compare the efficacy of oral bexarotene (LGD1069) at two different dose
levels in patients with advanced breast cancer. II. Assess the safety and tolerability of
this treatment regimen in this patient population. III. Evaluate the efficacy of oral
bexarotene in terms of induction of differentiation and decreased aberrant cell
proliferation in these patients.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to prior therapy for metastatic disease. Patients are randomized to one of two
dose levels. All patients receive oral bexarotene once daily. Treatment continues in the
absence of disease progression or unacceptable toxicity. Patients are followed every week
for the first month, at weeks 6 and 8, then monthly thereafter.
PROJECTED ACCRUAL: A total of 84-180 patients will be accrued for this study.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
George D. Demetri, MD
Study Chair
Dana-Farber Cancer Institute
United States: Federal Government
LIGAND-L1069-34
NCT00003752
October 1998
March 2003
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington, District of Columbia 20007 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Cancer Center, University of Virginia HSC | Charlottesville, Virginia 22908 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
Sarah Cannon-Minnie Pearl Cancer Center | Nashville, Tennessee 37203 |
Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Baptist Regional Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Oregon Cancer Center at Oregon Health Sciences University | Portland, Oregon 97201-3098 |
Michigan State University | East Lansing, Michigan 48824 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Mayo Clinic Jacksonville | Jacksonville, Florida 32224 |
Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
University of Minnesota | Minneapolis, Minnesota 55455 |