Clinical trial NCT01560195: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: NSCLC
Neutropenia
Febrile Neutropenia
Keywords: neutropenia
febrile neutropenia
chemotherapy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Rate of grade 3/4 neutropenia in cycle 1
timeFrame: 21 days
Secondary outcomes:
measure: Incidence of febrile neutropenia in cycle 1
timeFrame: 21 days
measure: Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4
timeFrame: Through 2 to 4 cycles
measure: Time to neutrophil recovery in the 4 chemotherapy cycles
timeFrame: Through 4 cycles
measure: Duration of 3/4 neutropenia in the 4 chemotherapy cycles
timeFrame: Through 4 cycles
measure: Objective response rate
timeFrame: Through 4 cycles
measure: Progress free survival
timeFrame: Through 4 cycles
measure: Overall survival
timeFrame: Through 4 cycles
measure: Exploratory biomarkers research
timeFrame: Through 4 cycles
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou
role: PRINCIPAL_INVESTIGATOR
References: