Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer

This study has been completed.
Sponsor:
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
Information provided by (Responsible Party):
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00146562
First received: September 2, 2005
Last updated: February 15, 2013
Last verified: February 2013
  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 2

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:


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
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Darbepoetin Alfa
    Given day before chemotherapy of red blood cell count is below normal
    Other Name: Aranesp
    Drug: Pegfilgrastim
    Given as an injection the day before chemotherapy for a total of 8 injections
    Other Name: Neulasta
    Drug: Paclitaxel
    As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
    Drug: Doxorubicin
    As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
    Drug: Cyclophosphamide
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Harold J. Burstein, MD, PhD
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 J. Burstein, MD, PhD, Associate Professor of Medicine, 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 15, 2013
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
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Paclitaxel
Darbepoetin alfa
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Hematinics

ClinicalTrials.gov processed this record on July 31, 2014