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

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Massachusetts General Hospital Beth Israel Deaconess Medical Center Lowell General Hospital Brigham and Women's Hospital North Shore Medical 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 Breast Cancer Stage II	Drug: Darbepoetin Alfa Drug: Pegfilgrastim Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 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

Other Name: Aranesp

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

Other Name: Neulasta

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
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
North Shore Cancer Center
Peabody, Massachusetts, United States, 01960

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Lowell General Hospital

Brigham and Women's Hospital

North Shore Medical Center

Investigators

Principal Investigator:

Harold Burstein, MD, PhD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Harold Burstein, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00146562 History of Changes
Other Study ID Numbers:	03-154
Study First Received:	September 2, 2005
Last Updated:	February 26, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

adjuvant chemotherapy
G-CSF
pegfilgrastim
darbepoetin alfa

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Cyclophosphamide
Doxorubicin
Paclitaxel
Darbepoetin alfa
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012