Randomized Phase II Study of Human C-Raf Kinase Antisense Oligonucleotide Isis 5132 (CGP 69846A) or Human Pkc-Alpha Antisence Oligonucleotide ISIS 3521 (CGP 64128A) in Women With Previously Treated Matastatic Breast Cancer
OBJECTIVES: I. Estimate the proportion of women with previously treated metastatic breast
cancer who are progression free at 4 months after receiving ISIS 5132 or ISIS 3521. II.
Determine duration of response to these treatment regimens in this patient population. III.
Evaluate toxicities and tolerability of these treatment regimens in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
number of prior therapies for metastatic breast cancer (1 vs 2). Patients are randomized to
one of two treatment arms. (Arm I closed 12/22/99) Arm I: Patients receive ISIS 5132 IV
continuously over 21 days. (closed 12/22/99) Arm II: Patients receive ISIS 3521 IV
continuously over 21 days. Treatment repeats every 4 weeks in the absence of disease
progression or unacceptable toxicity. After every 2 courses, patients are evaluated for
response. Patients are followed every 3 months for the first 2 years, every 6 months the
next 3 years, then annually thereafter.
PROJECTED ACCRUAL: A maximum of 68 patients (34 per arm) will be accrued in this study (Arm
I closed 12/22/99).
Allocation: Randomized, Primary Purpose: Treatment
William J. Gradishar, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Veterans Affairs Medical Center - Chicago (Lakeside)||Chicago, Illinois 60611|