Breast Cancer, Non Small Cell Lung Cancer
Conditions
Keywords
Neutropenia, Febrile neutropenia, PEG-rhG-CSF, Myelosuppressive chemotherapy
Brief summary
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
Interventions
DRUGYPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
DRUGYPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
DRUGYPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
DRUGPEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Sponsors
Xiamen Amoytop Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy * Karnofsky Score ≥ 70 * Life Expectancy \> 3 months * Age: 18～70yrs. * Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells. * Normal coagulation function, no evidences of hemorrhage tendency. * No exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion. * Adequate liver, cardiac, kidney function. Indicators of liver function test ≤ 2.5ULN, Indicators of kidney function test ≤ 1ULN * Understand and voluntarily sign an informed consent form.
Exclusion criteria
* Pregnant or lactating females * Evidence of tumor metastasis in bone marrow * Lack insight due to tumor metastasis in the central nervous system * Prior bone marrow transplant or stem cell transplant * Infective symptom before enrollment into this study * Other malignancy history * Known hypersensitivity to any component of the drug(e.g. rh-G-CSF) that to be administered * Subject enrolled in any other investigational drug or device trial within 3 months of informed consent date * Drug abuser or alcoholist * Prior radiotherapy or expected to received radiotherapy * Unstable or uncontrolled cardiac or hypertension * Other conditions which in the opinion of the investigator preclude enrollment into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles | 21 day | Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia in the two experimental cycles | 21 day | Febrile neutropenia means absolute neutrophil count is less than 500/mm3 or absolute neutrophil count between 500/mm3 and 1000mm3 but probably to decline to less than 500mm3 within 48hrs, and body temperature is higher than 38.5 degrees celsius or higher than 38.0 degrees celsius and lasting for more than 1hr |
| Diversification of neutrophil in the two experimental cycles | 21 day | — |
Countries
China
Outcome results
None listed