Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00010075
First received: February 2, 2001
Last updated: July 23, 2008
Last verified: June 2003
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Drug: mitoxantrone hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2000
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.

  Eligibility

Ages Eligible for Study:   75 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010075

Locations
France
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Polyclinique De Courlancy
Metz, France, 55038
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
C.H. Senlis
Senlis, France, 60309
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Elisabeth Carola, MD C.H. Senlis
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00010075     History of Changes
Other Study ID Numbers: CDR0000068439, FRE-GERCOR-SAM-S99-1, EU-20028
Study First Received: February 2, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorouracil
Mitoxantrone
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014