Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer

January 11, 2017 updated by: Memorial Sloan Kettering Cancer Center

Pilot Study of Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan-Kettering at Basking Ridge
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan-Kettering Cancer Center at Commack
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan-Kettering Cancer Center at Mercy
      • Sleepy Hollow, New York, United States, 10591
        • Memoral Sloan-Kettering Cancer Center at Phelps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Patients Who Completed 8 Cycles.
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Amgen

Investigators

  • Principal Investigator: Pamela Drullinsky, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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