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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01560195
• Other study ID #: HHPG-19K -III-02
• Status: Recruiting
• Phase: Phase 3
• First received: March 8, 2012
• Last updated: November 4, 2012
• Start date: April 2012

Study information

• Verified date: November 2012
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Caicun Zhou, M. D.
• Phone: 862165115006
• Email: caicunzhou[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Febrile Neutropenia
• Neutropenia
• NSCLC

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of grade 3/4 neutropenia in cycle 1	the rate of ANC lower than 1.0 × 109/L	21 days	No
Secondary	Incidence of febrile neutropenia in cycle 1	rate of ANC<1.0×109/L and auxiliary temperature>38.5?	21 days	No
Secondary	Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4	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	No
Secondary	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	No
Secondary	Duration of 3/4 neutropenia in the 4 chemotherapy cycles	duration of ANC lower than 1.0 × 109/L	Through 4 cycles	No
Secondary	Objective response rate		Through 4 cycles	No
Secondary	Progress free survival		Through 4 cycles	No
Secondary	Overall survival		Through 4 cycles	No
Secondary	Exploratory biomarkers research	Relationship between SNP and microRNA with myelosuppression and tumor response rate	Through 4 cycles	No