Full Text View
Tabular View
No Study Results Posted
Related Studies
Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, May 2009
First Received: February 1, 2008   Last Updated: May 6, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Amgen
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00615901
  Purpose

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
Breast Cancer
Drug: cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Cyclophosphamide Fluorouracil Methotrexate Filgrastim Pegfilgrastim
U.S. FDA Resources
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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • The primary objective of the study is to evaluate the feasibility and safety of this dose dense regimen. Delivered dose-intensity and specific toxicities will be assessed. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

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
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.
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.
2: Experimental
Cohort 2, will be treated at 10-11 day intervals and supported by filgrastim.
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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSKCC within 3 months of enrollment. Patients with inflammatory breast cancer are not eligible for the study. Pathology will be assessed in the standard fashion. Results of HER-2/neu, estrogen receptor, and progesterone receptor are required for study entry.
  • The patient cannot be Her-2/neu over-expressing either by immunohistochemistry or FISH as per hospital laboratory standard whether institutional or outside laboratory.
  • Patients must be > than or equal to 18 years of age
  • Patients must have a Karnofsky score of > than or equal to 80
  • Patients may have received hormonal therapy for the purpose of chemoprevention but must be willing to discontinue at least 24 hours prior to enrollment and while participating in this trial.
  • Patients will have completed their definitive breast surgery (mastectomy or breast conserving surgery)
  • Patients must be ready to begin therapy within 84 days from the final surgical procedure required to treat their primary tumor
  • Patients must be stage I-II
  • Absolute neutrophil count (ANC) > than or equal to 1500/µL and platelet count > than or equal to 100,000/µL
  • Total bilirubin must be < than or equal to 1.1 mg/dL or within normal institutional limits if outside MSKCC. Transaminases (SGOT/AST and/or SGPT/ALT) may be up to < than or equal to 92.5 U/L or < than or equal to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < than or equal to ULN.
  • Serum creatinine must be within 0.6-1.3 mg/dL or within normal institutional limits if outside MSKCC.
  • Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
  • Patients must give written, informed consent indicating their understanding and willingness to participate in the study.
  • Brachytherapy after lumpectomy is permitted.

Exclusion Criteria:

  • Stage III-IV breast cancer
  • Prior chemotherapy or radiation therapy is excluded except for brachytherapy.Radiation for patients on this protocol will be given, if indicated, after the completion of chemotherapy.
  • Pregnant or lactating patients
  • Patients with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease-free for at least five years.
  • Patients with unstable angina, congestive heart failure, current use of digitalis, betablockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or with a history of a myocardial infarction within 12 months.
  • Patients with a psychiatric illness that would prevent them from understanding the nature of the investigational therapy and complying with protocol requirements.
  • Patients with concurrent medical conditions, which, in the judgment of the investigator, would make them inappropriate candidates for study enrollment
  • Patients with active, unresolved infections
  • Patients that have known sensitivity to E. coli derived proteins, PEG-filgrastim, filgrastim, or any component products.
  • Patients must be Her 2/neu non-over-expressing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615901

Contacts
Contact: Pamela Drullinsky, MD drullinp@mskcc.org
Contact: Clifford Hudis, MD hudisc@mskcc.org

Locations
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            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Amgen
Investigators
Principal Investigator: Pamela Drullinsky, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by Memorial Sloan-Kettering Cancer Center:
cyclophosphamide
methotrexate
fluorouracil
PEG-filgrastim

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009