Clinical trial NCT00010075: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 75
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Metz
country: France
facility: Polyclinique De Courlancy
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
city: Senlis
country: France
facility: C.H. Senlis
city: Suresnes
country: France
facility: Centre Medico-Chirurgical Foch
Study officials:
affiliation: C.H. Senlis
name: Elisabeth Carola, MD
role: STUDY_CHAIR
References: