Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

Neutropenia Clinical Trial

— PEG-rhG-CSF  

Official title:

Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01918241
• Other study ID #: JY062013B
• Status: Recruiting
• Phase: Phase 2
• First received: August 6, 2013
• Last updated: November 9, 2015
• Start date: July 2013

Study information

• Verified date: November 2015
• Source: Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
• Contact: Yan Qin, M.D.
• Phone: 010-8778-8507
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.

Description:

The study consist of a screening period and a 21-day chemotherapy period of the same chemotherapy treatment cycle(s).Screening the subjects according to the inclusion criteria and exclusion criteria before 2 weeks of chemotherapy, and the screening successfully patients will be eligible for this study. The 1st chemotherapy treatment cycle defined as subjects screening period, subjects will be treated with the TC or EC regimen on the 1st day, aiming to screen out Chemotherapy-induced Neutropenia of ≥grade 3 (ANC＜1.0×10^9/L) who can have the eligible to enter the 2nd chemotherapy treatment cycle, otherwise to quit the study. On the 1st day in cycle 2, subjects will be treated with the same regimen as the 1st chemotherapy treatment cycle, and be received the test drugs or controlled from the 3rd day to observe the efficacy and safety.

【Primary Outcome Measures】:

• Duration of ≥grade 3 neutropenia in cycle 2

【Secondary Outcome Measures】:

• Incidence of ≥grade 3 neutropenia induce;

• Incidence of febrile neutropenia;

• Duration for ANC from chemotherapy finished to ANC nadir and the minimum ANC ;

• Duration for ANC recovery from nadir to 2.0×10^9/L.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age:18-70 years;

• Comfirmed advanced tumor patients by histopathological with regarding initialtreatment or adjuvant, or neoadjuvant chemotherapy,suitable for chemotherapy with canboplatin combined with taxol or cyclophosphamide combined with pharmorubicin in the opinion of the investigator;

• Performance status(EOCG)=1;

• Normal human peripheral blood are eligible for the chemotherapy, WBC=3,500 per cubic millilit, ANC = 1,500 per cubic milliliter, PLT = 100,000 per cubic milliliter;

• Normal ECG examination;

• Without liver metastasis patients: the level of ALT?TBIL?AST were in the 2.5 times of upper normal limit; Liver metastasis patients: the level of ALT?TBIL?AST were in the 5 times of upper normal limit;

• Renal function indices:the level of Cr?BUN were bothe in the 1.25 times of upper normal limit;

• Life expectancy >3 months;

• Signed informed consent.

Exclusion Criteria:

• Be treated with radiotherapy in nearly 4 weeks(not included local radiotherapy for the bone metastasis);

• Be treated with hemopoietic stem cell transplantation or bone marrow transplant;

• Not adequately controlled infections(e.g. ANC = 12,000 per cubic milliliter,temperature > 38.2?)

• Evidence of metastatic disease in bone marrow,or with other malignant tumors (not included cured basal cell carcinoma and endometrial carcinoma);

• Subjects with unconscious or symptomatic brain metastases;

• Subjects with serious heart?liver and renal disease;

• Subjects with serious diabetes or poor control in glycemia;

• Pregnant or breast-feeding period females;

• Be treated with antibiotics in 72 hours or currently being treated with antibiotics;

• Treated with PEG-rhG-CSF in past;

• Participated 3 or more than 3 clinical trials in nearly a year(as subjects) or any clinical trials in nearly 3 months;

• Allergic disorders or allergies subjects or known hypersensitivity to filgrastim or any of the products to be administered during dosing;

• Suspected or comfirmed evidences of drug?treatment of drugs or alcohol abused;

• Serious Neurological disorders that would affect the consent or observation;

• Other conditions which in the opinion of the investigator preclude enrollment into the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neutropenia

Intervention

Drug:
• pegfilgrastim,30mcg/kg
Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.
• pegfilgrastim, 60mcg/kg
Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
• pegfilgrastim, 100mcg/kg
Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
• filgrastim, 5mcg/kg
At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, CAMS	Beijing

Sponsors (12)

Lead Sponsor

Collaborator

Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Beijing Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Changsha Central Hospital, Jiangsu Cancer Institute & Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shandong Cancer Hospital and Institute, Subei People's Hospital of Jiangsu Province, The Affiliated Hospital of Inner Mongolia Medical University, The First Affiliated Hospital with Nanjing Medical University, Wuhan TongJi Hospital, Yangzhou No.1 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of =grade 3 neutropenia in cycle 2		21 days	No
Secondary	change of Neutropenia and ANC in cycle 2	Incidence of =grade 3 neutropenia; Incidence of febrile neutropenia; Measurement the duration from chemotherapy finished to the ANC reached the nadir and the value of ANC`s nadir; Time to ANC recovery,the time from chemotherapy administration until the patient`s ANC increasd to 2.0*109/L after the expected nadir	21 days	No