Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

July 23, 2008 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone.
  • Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients.
  • Determine the tolerance of these patients to this regimen.

OUTLINE: This is a multicenter study.

Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, after 3 courses, and at treatment completion.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Study Type

Interventional

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

  • France
      • Argenteuil, France, 95107
        • Centre Hospitalier Victor Dupouy
      • Metz, France, 55038
        • Polyclinique de Courlancy
      • Paris, France, 75970
        • Hopital Tenon
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Senlis, France, 60309
        • C.H. Senlis
      • Suresnes, France, 92151
        • Centre Medico-Chirurgical Foch

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

75 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic adenocarcinoma of the breast

  • Bidimensionally measurable or evaluable disease

    • At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR
    • Serous drainage, cutaneous metastasis, osseous metastasis, etc.
  • No symptomatic cerebral metastasis

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 75 to 90

Sex:

  • Female

Menopausal status:

  • Postmenopausal

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3

Hepatic:

  • Alkaline phosphatase less than 3 times normal
  • Bilirubin less than 1.5 times normal
  • Transaminases less than 3 times normal
  • Total protein greater than 60%
  • Albumin greater than 30 g/L

Renal:

  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • LVEF greater than 50% by echocardiogram or scintigraph
  • ECG normal
  • No uncontrolled angina
  • No myocardial infarction within past 6 months

Other:

  • No other medical illness or condition that would preclude study
  • No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
  • No psychological, social, familial, or geographical reasons that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior adjuvant chemotherapy allowed
  • No prior adjuvant anthracyclines
  • No prior chemotherapy for metastatic disease

Endocrine therapy:

  • One or two prior regimens of hormonal therapy allowed for metastatic disease

Radiotherapy:

  • No prior radiotherapy for metastatic disease

Surgery:

  • Not specified

Other:

  • No concurrent participation in another study

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

GERCOR - Multidisciplinary Oncology Cooperative Group

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, 2000

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

June 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068439
  • FRE-GERCOR-SAM-S99-1
  • EU-20028

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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