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Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
This study is ongoing, but not recruiting participants.
First Received: May 6, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00015886
  Purpose

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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Surgery
Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Docetaxel Leucovorin Calcium Folinic acid calcium salt pentahydrate
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Metastatic or unresectable local disease
  • Measurable or evaluable disease
  • No ascites or pleural effusion as only metastatic site
  • No brain or leptomeningeal metastases
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Granulocyte count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • Bilirubin normal
  • SGOT/SGPT less than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2.5 times ULN

Renal:

  • Creatinine no greater than 2 times ULN

Cardiovascular:

  • Adequate cardiac function
  • No history of significant atherosclerotic coronary disease (e.g., uncontrolled angina)
  • No history of significant cardiac arrhythmia

Other:

  • No serious medical or psychiatric illness that would preclude study
  • No active uncontrolled bacterial, viral, or fungal infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior high-dose chemotherapy and autologous transplantation

Chemotherapy:

  • At least 3 weeks since prior chemotherapy and recovered
  • No more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy)
  • No prior docetaxel
  • No prior high-dose chemotherapy and autologous transplantation
  • Prior paclitaxel allowed

Endocrine therapy:

  • No concurrent hormonal therapy, except as contraception

Radiotherapy:

  • At least 3 weeks since prior radiotherapy and recovered
  • Concurrent radiotherapy for relief of localized pain or obstruction allowed

Surgery:

  • At least 2 weeks since prior major surgery and recovered

Other:

  • No other concurrent cytotoxic agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015886

Locations
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
Sponsors and Collaborators
Wake Forest University
Investigators
Study Chair: Gretchen Kimmick, MD, MS Wake Forest University
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer

Study placed in the following topic categories:
Antimetabolites
Vitamin B Complex
Skin Diseases
Immunologic Factors
Breast Neoplasms
Leucovorin
Trace Elements
Immunosuppressive Agents
Recurrence
Docetaxel
Calcium, Dietary
Fluorouracil
Vitamins
Micronutrients
Breast Diseases

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009