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A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT01560195
Recruitment Status : Unknown
Verified November 2012 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 22, 2012
Last Update Posted : November 6, 2012
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

March 8, 2012
March 22, 2012
November 6, 2012
April 2012
January 2013   (Final data collection date for primary outcome measure)
Rate of grade 3/4 neutropenia in cycle 1 [ Time Frame: 21 days ]
the rate of ANC lower than 1.0 × 109/L
Same as current
Complete list of historical versions of study NCT01560195 on ClinicalTrials.gov Archive Site
  • Incidence of febrile neutropenia in cycle 1 [ Time Frame: 21 days ]
    rate of ANC<1.0×109/L and auxiliary temperature>38.5℃
  • Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through 4 cycles ]
    duration of ANC lower than 1.0 × 109/L
  • Objective response rate [ Time Frame: Through 4 cycles ]
  • Progress free survival [ Time Frame: Through 4 cycles ]
  • Overall survival [ Time Frame: Through 4 cycles ]
  • Exploratory biomarkers research [ Time Frame: Through 4 cycles ]
    Relationship between SNP and microRNA with myelosuppression and tumor response rate
  • Incidence of febrile neutropenia in cycle 1 [ Time Frame: 21 days ]
    rate of ANC<1.0×109/L and auxiliary temperature>38.5℃
  • Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4 [ Time Frame: 21 days ]
    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 [ Time Frame: 21 days ]
    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 [ Time Frame: 21 days ]
    duration of ANC lower than 1.0 × 109/L
  • Objective response rate [ Time Frame: 42 days ]
  • Progress free survival [ Time Frame: 42 days ]
  • Overall survival [ Time Frame: 42 days ]
  • Exploratory biomarkers research [ Time Frame: 42 days ]
    Relationship between SNP and microRNA with myelosuppression and tumor response rate
Not Provided
Not Provided
 
A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • NSCLC
  • Neutropenia
  • Febrile Neutropenia
  • Drug: Pegylated 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.
  • Drug: Pegylated rhG-CSF: 6mg
    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.
  • Drug: placebo 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.
  • Experimental: Pegylated rhG-CSF: 100µg/kg
    Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
    Intervention: Drug: Pegylated rhG-CSF: 100µg/kg
  • Experimental: Pegylated rhG-CSF: 6mg
    Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg
    Intervention: Drug: Pegylated rhG-CSF: 6mg
  • Placebo Comparator: Placebo
    Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4
    Intervention: Drug: placebo and rhG-CSF 5ug/kg/d
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
390
Not Provided
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01560195
HHPG-19K -III-02
No
Not Provided
Not Provided
Jiangsu HengRui Medicine Co., Ltd.
Jiangsu HengRui Medicine Co., Ltd.
Not Provided
Principal Investigator: Caicun Zhou Shanghai Pulmonary Hospital, Shanghai, China
Jiangsu HengRui Medicine Co., Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP