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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Amgen |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00615901 |
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.
Condition | Intervention |
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Breast Cancer |
Drug: cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer |
Estimated Enrollment: | 86 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.
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Drug: cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim
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.
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2: Experimental
Cohort 2, will be treated at 10-11 day intervals and supported by filgrastim.
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Drug: cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim
If Cohort 1 is deemed safe according to stopping criteria listed, the next cohort of patients, Cohort 2, C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 N (filgrastim/Neupogen ®) 300 mcg or 480 mcg. Eight doses of CMF q 10-11 days with filgrastim (Neupogen®) given days 1-5 beginning the day after chemotherapy. 300 μg/kg for patients < 60 kg or 480 μg for patients > or = to 60 kg subcutaneous from day 2 until day 8 (7 days).
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pamela Drullinsky, MD | drullinp@mskcc.org | |
Contact: Clifford Hudis, MD | hudisc@mskcc.org |
United States, New Jersey | |
Memorial Sloan-Kettering at Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Pamela Drullinsky, MD drullinp@mskcc.org | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center at Mercy | Recruiting |
Rockville Centre, New York, United States, 11570 | |
Contact: Pamela Drullinsky, MD drullinp@mskcc.org | |
Contact: Clifford Hudis, MD hudisc@mskcc.org | |
Principal Investigator: Pamela Drullinsky, MD | |
Memoral Sloan-Kettering Cancer Center at Phelps | Recruiting |
Sleepy Hollow, New York, United States, 10591 | |
Contact: Pamela Drullinsky, MD drullinp@mskcc.org | |
Memorial Sloan-Kettering Cancer Center at Commack | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Pamela Drullinsky, MD 212-639-6802 drullinp@mskcc.org | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Pamela Drullinsky, MD drullinp@mskcc.org | |
Principal Investigator: Pamela Drullinsky, MD |
Principal Investigator: | Pamela Drullinsky, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Pamela Drullinsky, MD ) |
Study ID Numbers: | 07-133 |
Study First Received: | February 1, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00615901 History of Changes |
Health Authority: | United States: Institutional Review Board |
cyclophosphamide methotrexate fluorouracil PEG-filgrastim |
Antimetabolites Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Cyclophosphamide Folic Acid Antagonists Immunosuppressive Agents |
Folic Acid Fluorouracil Methotrexate Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Reproductive Control Agents Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Alkylating Agents Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Breast Diseases Skin Diseases Breast Neoplasms Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Fluorouracil Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |