Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Massachusetts General Hospital Beth Israel Deaconess Medical Center Lowell General Hospital Faulkner Hospital North Shore Cancer Center
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00146562

Purpose

The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.

Condition	Intervention	Phase
Breast Cancer Stage I Breast Cancer Stage II Breast Cancer	Drug: Darbepoetin Alfa Drug: Pegfilgrastim Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet Pegfilgrastim Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	109
Study Start Date:	July 2003
Estimated Study Completion Date:	May 2008
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Intervention Details:

Given day before chemotherapy of red blood cell count is below normal

Given as an injection the day before chemotherapy for a total of 8 injections

As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles

Detailed Description:

Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment patients may receive an injection of darbepoetin alfa in addition to chemotherapy if their red blood cell count is below normal levels.
On the day after chemotherapy treatment, patients will receive an injection of pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total of 8 injections. Once the patient has finished chemotherapy and the last of the pegfilgrastim shots, their participation in this trial will be complete.
While on this study the following procedures will be performed: a physical exam will be done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2 weeks.
This study also involves a Quality of Life Questionnaire done at the beginning of study treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study treatment.
Patients will remain on this study unless they experience unacceptable side effects from any of the treatment drugs.

Eligibility

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

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed breast cancer clinical stage I, II or III disease. Patients must be deemed of sufficient risk for tumor or recurrence
Patients may receive the defined adjuvant chemotherapy treatment either following definitive breast surgery or prior to definitive breast surgery
18 years of age or older
ECOG performance status 0 or 1
ANC > 1,500/uL
Hemoglobin > 9 g/dL
Platelets > 100,000/ul
Total bilirubin less than or equal to ULN
AST/ALT < 1.5 x ULN
Creatinine within normal institutional limits
PT/PTT < institutional upper limit of normal
LVEF > 50%

Exclusion Criteria:

Previous cytotoxic chemotherapy or therapeutic radiation therapy
Pregnant or lactating women
Receiving any other investigational agents
Stage IV breast cancer
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pegfilgrastim or darbepoetin
Previous exposure to G-CSF or pegfilgrastim or to recombinant erythropoetin-related growth factors.
On antibiotics within 72 hours of registration
Patients with immune deficiency who are at increased risk of lethal infections when treated with marrow-suppressive therapy, or HIV-positive patients receiving anti-retroviral therapy
Sickle cell disease
Known positive antibody response to any erythropoietic agent
Known hematologic diseases
Known history of hyperviscosity syndrome
Patients on lithium
RBC transfusion within past 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146562

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
North Shore Cancer Center
Peabody, Massachusetts, United States, 01960
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Lowell General Hospital
Lowell, Massachusetts, United States, 01854

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Lowell General Hospital

Faulkner Hospital

North Shore Cancer Center

Investigators

Principal Investigator:

Harold Burstein, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Harold Burstein, MD )
Study ID Numbers:	03-154
Study First Received:	September 2, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00146562 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

adjuvant chemotherapy
G-CSF
pegfilgrastim
darbepoetin alfa

Study placed in the following topic categories:

Skin Diseases
Immunologic Factors
Hematinics
Darbepoetin alfa
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Cyclophosphamide
Immunosuppressive Agents

Doxorubicin
Anti-Bacterial Agents
Paclitaxel
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Alkylating Agents
Breast Diseases
Skin Diseases
Hematinics
Mitosis Modulators

Darbepoetin alfa
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Doxorubicin
Neoplasms
Paclitaxel
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 02, 2009