Drug Resistance Inhibition in Treating Women With Recurrent or Metastatic Breast Cancer
RATIONALE: Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a chemotherapy drug may reduce resistance to the drug, and allow the tumor cells to be killed.
PURPOSE: Phase II trial to study the effectiveness of PSC 883 and paclitaxel in treating women who have recurrent or metastatic breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST|
|Study Start Date:||June 1997|
|Primary Completion Date:||November 2003 (Final data collection date for primary outcome measure)|
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 annually thereafter.
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.
|United States, California|
|Veterans Affairs Medical Center - Palo Alto|
|Palo Alto, California, United States, 94304|
|Stanford University Medical Center|
|Stanford, California, United States, 94305-5408|
|United States, New Jersey|
|Hunterdon Regional Cancer Program|
|Flemington, New Jersey, United States, 08822|
|Kimball Medical Center|
|Lakewood, New Jersey, United States, 08701|
|Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County|
|Mount Holly, New Jersey, United States, 08060|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|St. Francis Medical Center|
|Trenton, New Jersey, United States, 08629|
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Robert W. Carlson, MD||Stanford University|