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

Sponsor

Harold J. Burstein, MD, PhD (Other)

Overall Status

Completed

CT.gov ID

NCT00146562

Collaborator

Dana-Farber Cancer Institute (Other), Massachusetts General Hospital (Other), Beth Israel Deaconess Medical Center (Other), Lowell General Hospital (Other), Brigham and Women's Hospital (Other), North Shore Medical Center (Other)

109

Enrollment

Locations

Duration (Months)

18.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Cancer Stage I Breast Cancer Stage II Breast Cancer	Drug: Darbepoetin Alfa Drug: Pegfilgrastim Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks. [2 years]

Secondary Outcome Measures

To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
3	Faulkner Hospital	Boston	Massachusetts	United States	02130
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Lowell General Hospital	Lowell	Massachusetts	United States	01854
6	North Shore Cancer Center	Peabody	Massachusetts	United States	01960