CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast cancer. The combination, of these three drugs, has been used for approximately 30 years in the treatment of breast cancer, and has been shown to be safe and effective. It is usually given every 3 weeks. Doctors believe, based on other breast cancer trials, that giving this type of chemotherapy in a shorter amount of time, every 2 weeks or sooner, instead of every 3 weeks, may be better. The purpose of this study is to test the safety of these drugs, given every 2 weeks or sooner, to treat breast cancer. Other breast cancer chemotherapy regimens have shown to be more beneficial when the drugs are given more frequently.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center at Mercy
Rockville Centre, New York, United States
Memoral Sloan-Kettering Cancer Center at Phelps
Sleepy Hollow, New York, United States
The Number of Patients Who Completed 8 Cycles.
the study regimen is deemed feasible and tolerable for patients with ANC \> 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles.
Time frame: 2 years
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