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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Experimental | Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg |
|
| Pegylated rhG-CSF: 6mg | Experimental | Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg |
|
| Placebo | Placebo Comparator | Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated rhG-CSF: 100µg/kg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of grade 3/4 neutropenia in cycle 1 | the rate of ANC lower than 1.0 × 109/L | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia in cycle 1 | rate of ANC<1.0×109/L and auxiliary temperature>38.5℃ | 21 days |
| Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caicun Zhou, M. D. | Contact | 862165115006 | 1053 | caicunzhou@yahoo.com.cn |
| Haoyuan Jiang, Ph. D. | Contact | 862168868768 | jianghy@shhrp.com |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou | Shanghai Pulmonary Hospital, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| Pegylated rhG-CSF: 6mg | Drug | 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. |
|
| placebo and rhG-CSF 5ug/kg/d | Drug | 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. |
|
The rate of ANC lower than 1.0 × 109 /L and rate of ANC<1.0×109/L and auxiliary temperature>38.5℃
| Through 2 to 4 cycles |
| Time to neutrophil recovery in the 4 chemotherapy cycles | After chemotherapy administration the time from the expected nadir until the patient's ANC increased to 2.0 × 109/L | Through 4 cycles |
| Duration of 3/4 neutropenia in the 4 chemotherapy cycles | duration of ANC lower than 1.0 × 109/L | Through 4 cycles |
| Objective response rate | Through 4 cycles |
| Progress free survival | Through 4 cycles |
| Overall survival | Through 4 cycles |
| Exploratory biomarkers research | Relationship between SNP and microRNA with myelosuppression and tumor response rate | Through 4 cycles |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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