Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery

August 9, 2018 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534
        • Southeastern Medical Oncology Center
      • Greenville, North Carolina, United States, 27858-4354
        • East Carolina University School of Medicine
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
      • Spartanburg, South Carolina, United States, 29303
        • Palmetto Hematology/Oncology Associates
    • Virginia
      • Richmond, Virginia, United States, 23298-0037
        • Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
Time Frame: 28 weeks
28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil
Time Frame: 28 weeks
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gretchen Kimmick, MD, MS, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1997

Primary Completion (Actual)

May 1, 2002

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

October 14, 2003

First Posted (Estimate)

October 15, 2003

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068567
  • CCCWFU-74896
  • NCI-3137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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