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

NCT00124111 | Completed Phase 2

• 1 other identifier: 20030156
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

clinical trial; pegfilgrastim; haematopoietic growth factor; neutropenia; CMF; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Interventions

pegfilgrastim DRUG

cyclophosphamide DRUG

methotrexate DRUG

5-fluorouracil DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Mattioli R, Gridelli C, Castellanos J, Duque A, Falcone A, Mansutti M, Bacon P, Lawrinson S, Skacel T, Casas A. Use of pegfilgrastim support on day 9 to maintain relative dose intensity of chemotherapy in breast cancer patients receiving a day 1 and 8 CMF regimen. Clin Transl Oncol. 2009 Dec;11(12):842-8. doi: 10.1007/s12094-009-0453-4.

  PMID: 20045791 RESULT

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia; Neoplasms

Interventions

pegfilgrastim; Cyclophosphamide; Methotrexate; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 25, 2005
• First Posted: July 27, 2005
• Last Updated: February 26, 2010

Record last verified: 2010-02