A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00124111
First received: July 25, 2005
Last updated: February 25, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV) CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage I-III breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: pegfilgrastim
Drug: cyclophosphamide
Drug: methotrexate
Drug: 5-fluorouracil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Single-arm Study Evaluating the Relative Dose Intensity of IV CMF Given on Day 1 and Day 8 With Pegfilgrastim Support in Subjects With Stage I-III Breast Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To assess the relative dose intensity (RDI) of IV CMF Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with Stage I-III breast cancer.

Secondary Outcome Measures:
  • Incidence of febrile neutropenic events over all cycles
  • Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
  • Safety profile over all cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Histologically confirmed breast cancer Stage I, II or III - Candidate for IV CMF chemotherapy (every 4 weeks) for a total of 6 cycles - Chemotherapy naïve (prior treatment with hormone therapy or with anti-HER2 monoclonal antibody therapy is permitted as long as treatment has been stopped prior to enrollment into the study) - Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L - Platelet count greater than or equal to 100 x 10^9/L - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Written informed consent before any study specific procedure Exclusion Criteria: - AST and/or ALT greater than 1.5 x upper limit of normal (ULN) concomitant with alkaline phosphatase greater than 2.5 x ULN according to institutional standard - Bilirubin greater than 2 x ULN according to institutional standard - Inadequate renal function (creatinine greater than 1.5 x ULN according to institutional standard) - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemias) - History of prior malignancy other than breast cancer with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy - Prior radiotherapy - Scheduled concomitant radiotherapy (e.g., radiotherapy administration while on study) - Documented active infection at the time of enrolment requiring use of systemic anti- infectives - Documented positive test for human immunodeficiency virus (HIV) infection - Known hypersensitivity to E coli derived products [e.g., Filgrastim (Neupogen®), pegfilgrastim (Neulasta®), HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®] - Subject is currently enrolled in or 30 days have not passed since completing other investigational device or drug trial(s) or is receiving other investigational agent(s) other than placebo (confirmation of prior treatment must be documented) - Pregnant or breast-feeding (for subjects of child bearing potential) - Not using adequate contraception (for subjects of child bearing potential) - Previous participation in this study - Inability or unwillingness to comply with the protocol procedures

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00124111

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00124111     History of Changes
Other Study ID Numbers: 20030156
Study First Received: July 25, 2005
Last Updated: February 25, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Amgen:
clinical trial
pegfilgrastim
haematopoietic growth factor
neutropenia
CMF
Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Fluorouracil
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014