Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer
Intervention: Darbepoetin Alfa (Drug); Pegfilgrastim (Drug); Paclitaxel (Drug); Doxorubicin (Drug); Cyclophosphamide (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
Harold Burstein, MD, PhD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
Official title: A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.
Secondary outcome: To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
Lowell General Hospital, Lowell, Massachusetts 01854, United States
Faulkner Hospital, Boston, Massachusetts 02130, United States
North Shore Cancer Center, Peabody, Massachusetts 01960, United States
Additional Information
Starting date: July 2003
Ending date: May 2008
Last updated: December 20, 2007
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