Febrile Neutropenia, Neutropenia, NSCLC
Conditions
Keywords
neutropenia, febrile neutropenia, chemotherapy
Brief summary
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.
Interventions
DRUGPegylated rhG-CSF: 100µg/kg
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.
Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.
DRUGplacebo and rhG-CSF 5ug/kg/d
Patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF 5ug/kg/d in cycle 2 to 4. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\[AUC\] 5 or cisplatin 75 mg/m2.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Investigator diagnosis of staged III or IV NSCLC * Age 18 to 70 years * ECOG performance status ≤ 1 * Chemotherapy naïve * Body weight ≥ 45kg * Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L * Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN
Exclusion criteria
* History of systematic chemotherapy or radical radiation therapy * Prior bone marrow or stem cell transplantation * Received systemic antibiotics treatment within 72 h of chemotherapy * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of grade 3/4 neutropenia in cycle 1 | 21 days | the rate of ANC lower than 1.0 × 109/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4 | Through 2 to 4 cycles | The rate of ANC lower than 1.0 × 109 /L and rate of ANC\<1.0×109/L and auxiliary temperature\>38.5℃ |
| Time to neutrophil recovery in the 4 chemotherapy cycles | Through 4 cycles | After chemotherapy administration the time from the expected nadir until the patient's ANC increased to 2.0 × 109/L |
| Duration of 3/4 neutropenia in the 4 chemotherapy cycles | Through 4 cycles | duration of ANC lower than 1.0 × 109/L |
| Incidence of febrile neutropenia in cycle 1 | 21 days | rate of ANC\<1.0×109/L and auxiliary temperature\>38.5℃ |
| Progress free survival | Through 4 cycles | — |
| Overall survival | Through 4 cycles | — |
| Exploratory biomarkers research | Through 4 cycles | Relationship between SNP and microRNA with myelosuppression and tumor response rate |
| Objective response rate | Through 4 cycles | — |
Countries
China
Contacts
Primary ContactCaicun Zhou, M. D.
Backup ContactHaoyuan Jiang, Ph. D.
Outcome results
None listed