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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001239
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
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.

Condition Intervention Phase
Breast Cancer Breast Neoplasms Drug: FLAC with GM-CSF Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Combination Chemotherapy (FLAC) Combined With Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: July 1989
Estimated Study Completion Date: January 2001
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001239


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001239     History of Changes
Other Study ID Numbers: 890119
89-C-0119
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: April 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
5-Fluorouracil
Adriamycin
Breast Carcinoma
Leucovorin
Phase II

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases