A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST
OBJECTIVES: I. Evaluate the antitumor activity, as measured by frequency of objective
response and time to progression, of the multidrug resistance modulator PSC 833 in
combination with paclitaxel in women with recurrent or metastatic breast cancer. II.
Describe the toxicity of this regimen.
OUTLINE: All patients receive PSC 833 by mouth every 6 hours for a total of 12 doses.
Paclitaxel is infused over 3 hours, after the 5th dose of PSC 833. Treatment is repeated
every 3 weeks in stable and responding patients. PSC 833 must not be mixed with grapefruit
juice. Growth factors may be used at the discretion of the investigator. Patients are
followed every 3 months for the first two years, then every 6 months for years 2-5, and then
PROJECTED ACCRUAL: It is anticipated that approximately 36 patients will be entered over 24
months if there are at least 6 responses in the first 17 patients.
Primary Purpose: Treatment
Robert W. Carlson, MD
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|Stanford University Medical Center||Stanford, California 94305-5408|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County||Mount Holly, New Jersey 08060|
|St. Francis Medical Center||Trenton, New Jersey 08629|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Veterans Affairs Medical Center - Palo Alto||Palo Alto, California 94304|
|Hunterdon Regional Cancer Program||Flemington, New Jersey 08822|
|Kimball Medical Center||Lakewood, New Jersey 08701|