CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY
70 Years
N/A
Both
Breast Cancer
Trial Information
CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY
OBJECTIVES: I. Determine the response rate and duration of response of elderly patients with
advanced breast cancer treated with first-line chemotherapy with mitigated "classical" CMF
(cyclophosphamide/methotrexate/fluorouracil) vs. mitoxantrone (DHAD). II. Define the
morbidity of CMF and DHAD in elderly patients. III. Determine quality of life in these
patients.
OUTLINE: This is a randomized study. Patients are stratified by participating institution.
The first group receives oral cyclophosphamide on days 1 through 14 and intravenous
methotrexate and fluorouracil on days 1 and 8. Courses repeat every 4 weeks for a maximum of
6 courses. The second group receives intravenous mitoxantrone every 3 weeks for a maximum of
8 courses. Concomitant therapy with hepatotoxic or nephrotoxic drugs (e.g., NSAIDs) or
corticosteroids (even as antiemetics) is not permitted in either group. Radiotherapy is
allowed provided no more than 50% of the bone marrow is irradiated and at least 1 indicator
lesion is unirradiated. Patients who complete therapy are followed every 3 months until
disease progression.
PROJECTED ACCRUAL: 60 patients will be accrued over approximately 1 year. If extreme
differences between arms exist after entry of 30 patients, accrual may be stopped early.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven, progressive, recurrent or metastatic
breast cancer in patients over 70 years of age Measurable or evaluable disease required,
including: Lesions of the mediastinum, retroperitoneum, or liver at least 3 cm in diameter
on CT scan or ultrasound The following are not considered measurable or evaluable:
Lymphedema Hilar enlargement Pleural effusion Ascites Bone marrow infiltration
Osteoblastic skeletal lesion No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Over 70 Sex: Not specified Menopausal status: Postmenopausal
Performance status: WHO 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000
Hepatic: Bilirubin less than 1.4 mg/dL (25 micromoles/L) Renal: Creatinine clearance
(calculated) greater than 50 mL/min in patients weighing at least 45 kg and measured
creatinine clearance at least 50 mL/min in patients weighing less than 45 kg
Cardiovascular: No congestive heart failure No myocardial infarction within 6 months No
severe arrhythmia No complete bundle branch block Other: No active uncontrolled infection
No mental disorders that may preclude patient follow-up No second malignancy except:
Adequately treated basal cell carcinoma of the skin Adequately treated in situ carcinoma
of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for advanced disease At least 1 year since prior adjuvant chemotherapy
Endocrine therapy: At least 4 weeks since prior estrogens, androgens, and progestins
Tamoxifen or aminoglutethimide allowed with no waiting period if disease progresses
Recovery from prior hormonal therapy for metastatic disease required Radiotherapy: Prior
radiotherapy allowed provided: Evaluable disease exists outside of treatment field No
greater than 50% of bone marrow was irradiated Surgery: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Marianne A. Nooij, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Leiden University Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000077804
NCT ID:
NCT00002498
Start Date:
July 1992
Completion Date:
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
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