The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.0 sites420 target enrollmentApril 2013

ConditionsMalignant Solid Tumors

InterventionsPEG-rhG-CSF

DrugsPEG-rhG-CSF

Overview

Phase: Phase 4
Intervention: PEG-rhG-CSF
Conditions: Malignant Solid Tumors
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Enrollment: 420
Primary Endpoint: The severity of adverse event during at least three consecutive cycles chemotherapy
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with age ≥ 18 years
•diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer
•Karnofsky Performance Status ≥ 70
•life expectancy of at least 3 months
•Written informed consent are acquired

Exclusion Criteria

•uncontrolled infection,Temperature is 38.0 ℃ or higher
•pregnancy
•Other situations that investigators consider as contra-indication for this study

Arms & Interventions

PEG-rhG-CSF

patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.

Intervention: PEG-rhG-CSF

Outcomes

Primary Outcomes

The severity of adverse event during at least three consecutive cycles chemotherapy

Time Frame: up to 30 days after the patient study completion

The occurrence rate of adverse event during at least three consecutive cycles chemotherapy

Time Frame: up to 30 days after the patient study completion

Secondary Outcomes

the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy(through the study completion,an average of 5 months)
the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy(through the study completion,an average of 5 months)