Combination Chemotherapy (FLAC) Combined With Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer

March 3, 2008 updated by: National Cancer Institute (NCI)
To evaluate a dose intensive chemotherapy regimen for the treatment of locally advanced and metastatic breast cancer using granulocyte-macrophage colony-stimulating factor (GM-CSF) to ameliorate chemotherapy-induced toxicity. Combination chemotherapy consists of Flurouricil, Leucovorin, Adriamycin, and Cytoxan (FLAC) which will be given every 21 days for 10 cycles. This protocol will replace the phase I study of this regimen (MB-232/88-C-0207) which found the MTD of this regimen to be at the first dose level. This is a phase II study to determine response rates of this regimen in advanced breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate a dose intensive chemotherapy regimen for the treatment of locally advanced and metastatic breast cancer using granulocyte-macrophage colony-stimulating factor (GM-CSF) to ameliorate chemotherapy-induced toxicity. Combination chemotherapy consists of Flurouricil, Leucovorin, Adriamycin, and Cytoxan (FLAC) which will be given every 21 days for 10 cycles. This protocol will replace the phase I study of this regimen (MB-232/88-C-0207) which found the MTD of this regimen to be at the first dose level. This is a phase II study to determine response rates of this regimen in advanced breast cancer.

Study Type

Interventional

Enrollment

100

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
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

All stage III or clinical T3N0 or TxN2 patients must have a histologically documented diagnosis of breast carcinoma and evaluate disease in the breast or axilla.

Patients with stage III must enter this protocol within 12 weeks of the initial diagnosis.

Patients with Stage IV (metastatic) breast cancer must have histologically proven diagnosis and must have evaluate disease. Patients with bone-only disease may be considered eligible after discussion with Dr. Kenneth Cowan.

For Stage III disease, there must be no history of prior cytotoxic therapy.

Stage IV patients will be eligible if they have had prior adjuvant chemotherapy and/or hormonal therapy provided the regimen did not included adriamycin. Patients will also be eligible if they have been treated with one prior Phase I or II single chemotherapy agent on a Medicine branch protocol. Patients who have had prior radiation therapy may be eligible providing there was not extensive radiation to the cardiac area.

There must be no history of previous malignancy except for cured non-melanoma skin cancer (basal cell carcinoma) and cervical cancer in situ.

Performance status (Karnofsky scale) must be greater than 70.

WBC count greater than 4000/mm3 and platelet count 100,000/mm3, unless there is evidence of bone marrow involvement with tumor.

Liver function tests (SGOT, Alk. Phosph., and T. Bilil) should be less than 1.5 times the upper limits of normal, and serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min unless these abnormalities are due to tumor involvement.

The patient must give informed consent.

No pregnant patients may be entered on this study; all patients should be informed about the need for contraception.

No history of other malignant neoplasms except for curatively treated basal cell skin cancer or surgically cured carcinoma of the cervix in situ.

Patients must not be in poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them being subjected to any treatments in this protocol.

Patients with a history of cardiac disease must have a normal ejection fraction by MUGA Scan and have no angina.

Must not have evidence of CNS metastasis.

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

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 1989

Primary Completion

December 7, 2022

Study Completion

January 1, 2001

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

April 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 890119
  • 89-C-0119

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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