This trial is active, not recruiting.

Condition breast cancer
Treatments fluorouracil, leucovorin calcium, mitoxantrone hydrochloride
Phase phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date January 2000
Trial identifier NCT00010075, CDR0000068439, EU-20028, FRE-GERCOR-SAM-S99-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Female participants from 75 years up to 90 years old.

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

Additional Information

Official title Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).