Feasibility and safety of avoiding granulocyte colony-stimulating

Submitted by aschwalb on Thu, 08/10/2017 - 14:15
Study ID
DFCI 15-516
Trial Conditions New
Study Information

Traditionally, Taxol chemotherapy administered every 2 weeks (called “dose dense”) includes Neulasta (Pegfilgrastim) the day after treatment to speed the recovery of the white blood cell count in order to maximize the chances that the next cycle of chemotherapy can be given on time.

In this research study, we are testing the safety and feasibility of delivering 4
cycles of dose-dense Taxol without the use of Neulasta as a growth factor
support. We want to see if Neulasta is necessary during this phase of chemotherapy and if there are less side effects without its use.
If you are found to need Neulasta (for example, because of low blood counts), the study has guidance for your study doctor for you to still be able to receive it.

Physician
Contact Information

Wendy Loeser RN OCN
Clinical Research
Dana-Farber Cancer Institute at
St. Elizabeth's Medical Center
736 Cambridge St
Boston, MA 02135
617-789-3385
Wendy_loeser@DFCI.harvard.edu

Clinical Trial Department
Purpose of Trial
Are you a breast cancer patient who is about to start taxol treatment with an every 2-week schedule?

In this research study, we are testing the safety and feasibility of delivering 4
cycles of dose-dense Taxol chemotherapy without the use of Neulasta support.
Phase
2
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Eligibility

 You are currently receiving or have completed 4 cycles of dose dense AC (Adriamycin/Cyclophosphamide) chemotherapy treatment.

 Your blood counts meet the study criteria.

 You are 18 to 64 years of age.

You may not be eligible to participate if:

 You had at least one episode of fever and neutropenia (low white blood cell counts) during the AC treatment.

 You are receiving any investigational agents.

 You are receiving any prohibited medications.

 You are pregnant or nursing.

 You have received other chemotherapy regimens in the last 5 years.