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

This study is currently recruiting participants.
Verified November 2012 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01560195
First received: March 8, 2012
Last updated: November 4, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
NSCLC
Neutropenia
Febrile Neutropenia
Drug: Pegylated rhG-CSF: 100µg/kg
Drug: Pegylated rhG-CSF: 6mg
Drug: placebo and rhG-CSF 5ug/kg/d
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • Rate of grade 3/4 neutropenia in cycle 1 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    the rate of ANC lower than 1.0 × 109/L


Secondary Outcome Measures:
  • Incidence of febrile neutropenia in cycle 1 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    duration of ANC lower than 1.0 × 109/L

  • Objective response rate [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]
  • Progress free survival [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]
  • Exploratory biomarkers research [ Time Frame: Through 4 cycles ] [ Designated as safety issue: No ]
    Relationship between SNP and microRNA with myelosuppression and tumor response rate


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegylated rhG-CSF: 100µg/kg
Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg
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.
Experimental: Pegylated rhG-CSF: 6mg
Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg
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.
Placebo Comparator: Placebo
Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560195

Contacts
Contact: Caicun Zhou, M. D. 862165115006 ext 1053 caicunzhou@yahoo.com.cn
Contact: Haoyuan Jiang, Ph. D. 862168868768 jianghy@shhrp.com

Locations
China, Shanghai
Shanghai Pulmonary Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Caicun Zhou, M. D.       caicunzhou@yahoo.com.cn   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: Caicun Zhou Shanghai Pulmonary Hospital, Shanghai, China
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01560195     History of Changes
Other Study ID Numbers: HHPG-19K -III-02
Study First Received: March 8, 2012
Last Updated: November 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
neutropenia
febrile neutropenia
chemotherapy

Additional relevant MeSH terms:
Neutropenia
Carcinoma, Non-Small-Cell Lung
Fever
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014