Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
This study has been completed.
Sponsor:
Harold J. Burstein, MD, PhD
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
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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:
Genetics Home Reference related topics:
breast 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 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
- 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
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 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 June 18, 2013