Loading clinical trials...
Loading clinical trials...
A PILOT PHASE II TRIAL OF PSC 833 MODULATION OF MULTIDRUG RESISTANCE TO PACLITAXEL IN THE TREATMENT OF METASTATIC CARCINOMA OF THE BREAST
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.
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.
Age
18 - 120 years
Sex
FEMALE
Healthy Volunteers
No
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States
Stanford University Medical Center
Stanford, California, United States
Hunterdon Regional Cancer Program
Flemington, New Jersey, United States
Kimball Medical Center
Lakewood, New Jersey, United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
St. Francis Medical Center
Trenton, New Jersey, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Start Date
August 14, 1997
Primary Completion Date
November 1, 2003
Last Updated
June 7, 2023
36
ESTIMATED participants
paclitaxel
DRUG
valspodar
DRUG
Lead Sponsor
Eastern Cooperative Oncology Group
Collaborators
NCT05673200
NCT05245812
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions