chemotherapy-induced neutropenia (CIN)
Conditions
Interventions
Escalating doses of 10, 20, or 30 *g/kg, by subcutaneous injection, once per
chemotherapy cycle
OR
Neulasta® (pegfilgrastim) 6 mg/0.6 mL fixed dose by subcutaneous injection once
per chemotherapy
Sponsors
Prolong Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult female patients, 18 years of age or older;2. Signed and dated written consent/assent by the patient or legally authorized representative;3. Histologically confirmed non-metastatic breast cancer;4. ECOG performance status * 2;5. Myelosuppressive chemotherapy naive;6. Scheduled to receive and anticipated to complete the following chemotherapy regimen:;a) FEC (fluorouracil/epirubicin (100)/cyclophosphamide)(3 cycles); ;b) Docetaxel (3 cycles) chemotherapy;7. White blood cell (WBC) * 3 × 109/L; Absolute neutrophil count (ANC) * 2.0 × 109/L; platelet count * 100 × 109/L; and hemoglobin * 10 g/dL (6.2 mmol/L);8. Adequate cardiac function (e.g., LVEF > 50% as determined by standard care) and adequate hepatic function (e.g., liver transaminases
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to E.coli derived products or polyethylene glycol;2. No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated *5 years ago with curative intent;3. Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease;4. Clinical diagnosis or history of chronic infection such as hepatitis B virus(HBV), hepatitis C Virus (HCV) or Human immunodeficiency virus(HIV) or history of tuberculosis;5. Previous exposure to filgrastim, pegfilgrastim or lipegfilgrastim within 30 days before randomization;6. Treatment with systemically active antibiotics within 72 hours before chemotherapy;7. Chronic use of oral corticosteroids;8. Participation in a clinical pharmacological trial within 30 days before randomization;9. Clinical diagnosis of drug abuse or substance abuse within 30 days prior to screening;10. Documented alcohol abuse within 30 days prior to screening.;11. Unwilling and/or not capable of ensuring compliance with the provisions of the study protocol;12. Pregnant or breastfeeding women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum HCG laboratory test;13. Other serious medical condition that would prevent individual from receiving protocol treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first cycle of chemotherapy (FE100C).. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the fourth cycle of chemotherapy (docetaxel). - Duration of severe neutropenia (ANC 2.0 x 109/L) during the first chemotherapy cycle (21-day cycle) - Duration of severe neutropenia (ANC | — |
Countries
Netherlands
Outcome results
None listed