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Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
fluorouracil
leucovorin calcium
mitoxantrone hydrochloride
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

75 Years - 90 Years (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Victor Dupouy
  • Polyclinique De Courlancy
  • Hopital Saint Antoine
  • Hopital Tenon
  • C.H. Senlis
  • Centre Medico-Chirurgical Foch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
July 23, 2008
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00010075
Brief Title
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Official Title
Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2003
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Carola, MD
Organizational Affiliation
C.H. Senlis
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Polyclinique De Courlancy
City
Metz
ZIP/Postal Code
55038
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Centre Medico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

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