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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

Primary Purpose

NSCLC, Neutropenia, Febrile Neutropenia

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Pegylated rhG-CSF: 100µg/kg

Pegylated rhG-CSF: 6mg

placebo and rhG-CSF 5ug/kg/d

About this trial

This is an interventional prevention trial for NSCLC focused on measuring neutropenia, febrile neutropenia, chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Pegylated rhG-CSF: 100µg/kg

Pegylated rhG-CSF: 6mg

Placebo

Arm Description

Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg

Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg

Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4

Outcomes

Primary Outcome Measures

Rate of grade 3/4 neutropenia in cycle 1

the rate of ANC lower than 1.0 × 109/L

Secondary Outcome Measures

Incidence of febrile neutropenia in cycle 1

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

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

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

duration of ANC lower than 1.0 × 109/L

Objective response rate

Progress free survival

Overall survival

Exploratory biomarkers research

Relationship between SNP and microRNA with myelosuppression and tumor response rate

Full Information

NCT ID

NCT01560195

First Posted

March 8, 2012

Last Updated

November 4, 2012

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01560195

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC, Neutropenia, Febrile Neutropenia

Keywords

neutropenia, febrile neutropenia, chemotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pegylated rhG-CSF: 100µg/kg

Arm Type

Experimental

Arm Description

Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg

Arm Title

Pegylated rhG-CSF: 6mg

Arm Type

Experimental

Arm Description

Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4

Intervention Type

Drug

Intervention Name(s)

Pegylated rhG-CSF: 100µg/kg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Pegylated rhG-CSF: 6mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo and rhG-CSF 5ug/kg/d

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of grade 3/4 neutropenia in cycle 1

Description

the rate of ANC lower than 1.0 × 109/L

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Incidence of febrile neutropenia in cycle 1

Description

rate of ANC<1.0×109/L and auxiliary temperature>38.5℃

Time Frame

21 days

Title

Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4

Description

The rate of ANC lower than 1.0 × 109 /L and rate of ANC<1.0×109/L and auxiliary temperature>38.5℃

Time Frame

Through 2 to 4 cycles

Title

Time to neutrophil recovery in the 4 chemotherapy cycles

Description

After chemotherapy administration the time from the expected nadir until the patient's ANC increased to 2.0 × 109/L

Time Frame

Through 4 cycles

Title

Duration of 3/4 neutropenia in the 4 chemotherapy cycles

Description

duration of ANC lower than 1.0 × 109/L

Time Frame

Through 4 cycles

Title

Objective response rate

Time Frame

Through 4 cycles

Title

Progress free survival

Time Frame

Through 4 cycles

Title

Overall survival

Time Frame

Through 4 cycles

Title

Exploratory biomarkers research

Description

Relationship between SNP and microRNA with myelosuppression and tumor response rate

Time Frame

Through 4 cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caicun Zhou, M. D.

Phone

862165115006

Ext

1053

caicunzhou@yahoo.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Haoyuan Jiang, Ph. D.

Phone

862168868768

jianghy@shhrp.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caicun Zhou

Organizational Affiliation

Shanghai Pulmonary Hospital, Shanghai, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Pulmonary Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caicun Zhou, M. D.

caicunzhou@yahoo.com.cn

12. IPD Sharing Statement

Learn more about this trial

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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