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Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia (PEG-rhG-CSF)

Primary Purpose

Neutropenia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pegfilgrastim,30mcg/kg
pegfilgrastim, 60mcg/kg
pegfilgrastim, 100mcg/kg
filgrastim, 5mcg/kg
Sponsored by
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia focused on measuring Pegylation, G-CSF, Efficacy, Satety

Eligibility Criteria

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

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.

Sites / Locations

  • Cancer Institute and Hospital, CAMSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

pegfilgrastim,30mcg/kg

pegfilgrastim, 60mcg/kg

pegfilgrastim,100mcg/kg

filgrastim,5mcg/kg

Arm Description

On the 3rd day and 6th day in Cycle 2, mean after 48h and 120h of chemotherapy, subjects will be received PEG-rhG-CSF(sc) in a fixed time(9:00±30 min), and the dosage is 30 mcg/kg.

On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 60 mcg/kg.

On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 100 mcg/kg.

On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to controlled group with rhG-CSF(sc, once a day) in a fixed time(9:00±30 min), and the dosage is 5mcg/kg, rhG-CSF must be injected for a continous 14 days, or twice observed the results for ANC from the nadir to counts≥5.0×10^9/L, but at least 7 days.

Outcomes

Primary Outcome Measures

Duration of ≥grade 3 neutropenia in cycle 2

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2013
Last Updated
November 9, 2015
Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, School of Medicine, Zhejiang University, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital with Nanjing Medical University, Wuhan TongJi Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Shandong Cancer Hospital and Institute, Changsha Central Hospital, Yangzhou No.1 People's Hospital, Subei People's Hospital of Jiangsu Province
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1. Study Identification

Unique Protocol Identification Number
NCT01918241
Brief Title
Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
Acronym
PEG-rhG-CSF
Official Title
Saftey and Efficacy Phase II Study of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University Cancer Hospital & Institute, Second Affiliated Hospital, School of Medicine, Zhejiang University, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital with Nanjing Medical University, Wuhan TongJi Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Shandong Cancer Hospital and Institute, Changsha Central Hospital, Yangzhou No.1 People's Hospital, Subei People's Hospital of Jiangsu Province

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
Keywords
Pegylation, G-CSF, Efficacy, Satety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pegfilgrastim,30mcg/kg
Arm Type
Experimental
Arm Description
On the 3rd day and 6th day in Cycle 2, mean after 48h and 120h of chemotherapy, subjects will be received PEG-rhG-CSF(sc) in a fixed time(9:00±30 min), and the dosage is 30 mcg/kg.
Arm Title
pegfilgrastim, 60mcg/kg
Arm Type
Experimental
Arm Description
On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 60 mcg/kg.
Arm Title
pegfilgrastim,100mcg/kg
Arm Type
Experimental
Arm Description
On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to PEG-rhG-CSF(sc, single) in a fixed time(9:00±30 min), and the dosage is 100 mcg/kg.
Arm Title
filgrastim,5mcg/kg
Arm Type
Experimental
Arm Description
On the 3rd day in Cycle 2, mean after 48h of chemotherapy, subjects will be assigned to controlled group with rhG-CSF(sc, once a day) in a fixed time(9:00±30 min), and the dosage is 5mcg/kg, rhG-CSF must be injected for a continous 14 days, or twice observed the results for ANC from the nadir to counts≥5.0×10^9/L, but at least 7 days.
Intervention Type
Drug
Intervention Name(s)
pegfilgrastim,30mcg/kg
Other Intervention Name(s)
PEG-rhG-CSF,30mcg/kg
Intervention Description
Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.
Intervention Type
Drug
Intervention Name(s)
pegfilgrastim, 60mcg/kg
Other Intervention Name(s)
PEG-rhG-CSF,60mcg/kg
Intervention Description
Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
Intervention Type
Drug
Intervention Name(s)
pegfilgrastim, 100mcg/kg
Other Intervention Name(s)
PEG-rhG-CSF,100mcg/kg
Intervention Description
Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
Intervention Type
Drug
Intervention Name(s)
filgrastim, 5mcg/kg
Other Intervention Name(s)
rhG-CSF,5mcg/kg
Intervention Description
At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.
Primary Outcome Measure Information:
Title
Duration of ≥grade 3 neutropenia in cycle 2
Time Frame
21 days
Secondary Outcome Measure Information:
Title
change of Neutropenia and ANC in cycle 2
Description
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
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Qin, M.D.
Phone
010-8778-8507
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute and Hospital, CAMS
City
Beijing
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia

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