Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00015886 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: docetaxel Drug: fluorouracil Drug: leucovorin calcium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer |
Study Start Date: | May 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1082 | |
East Carolina University School of Medicine | |
Greenville, North Carolina, United States, 27858-4354 | |
Southeastern Medical Oncology Center | |
Goldsboro, North Carolina, United States, 27534 | |
United States, South Carolina | |
Cancer Centers of the Carolinas | |
Greenville, South Carolina, United States, 29605 | |
Palmetto Hematology/Oncology Associates | |
Spartanburg, South Carolina, United States, 29303 | |
United States, Virginia | |
Massey Cancer Center | |
Richmond, Virginia, United States, 23298-0037 |
Study Chair: | Gretchen Kimmick, MD, MS | Wake Forest University |
Study ID Numbers: | CDR0000068567, CCCWFU-74896, NCI-3137 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00015886 History of Changes |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer stage IIIB breast cancer |
Antimetabolites Vitamin B Complex Skin Diseases Immunologic Factors Breast Neoplasms Leucovorin Trace Elements Immunosuppressive Agents |
Recurrence Docetaxel Calcium, Dietary Fluorouracil Vitamins Micronutrients Breast Diseases |
Antimetabolites Vitamin B Complex Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Breast Neoplasms Leucovorin |
Immunosuppressive Agents Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Fluorouracil Micronutrients Breast Diseases |