Loading clinical trials...
Loading clinical trials...
Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.
OBJECTIVES: * Determine the response rate in women with locally unresectable or metastatic breast cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or third-line chemotherapy. * Evaluate the toxic effects of this regimen in these patients. * Determine the time to progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for 2-8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 44 months.
Age
18 - 120 years
Sex
FEMALE
Healthy Volunteers
No
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, United States
Massey Cancer Center
Richmond, Virginia, United States
Start Date
January 1, 1997
Primary Completion Date
May 1, 2002
Completion Date
July 1, 2009
Last Updated
August 13, 2018
25
ACTUAL participants
docetaxel
DRUG
fluorouracil
DRUG
Lead Sponsor
Wake Forest University Health Sciences
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